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HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM;
K-NUMBER: K101907;
APPLICANT: HAEMONETICS CORP.;
CONTACT: GREG CALDER;
ADDRESS: 400 WOOD RD.;, P.O. BOX 9114;, BRAINTREE;, MA;, 2184;
DATE RECEIVED: 08/07/2010;
DECISION DATE: 10/12/2010;
REVIEW ADVISORY BOARD: CV;
MEDICAL SPECIALTY: ANAESTHESIA
PRODUCT CODE: CAC;
TYPE OF SUBMISSION: Traditional;
CLASSIFICATION OF DEVICE: Class 2;
APPLICABLE CFR REGULATION: 868.58299999999997;
DEFINITION: ;
TECHNICAL METHOD: ;
TARGET AREA: ;
There are numerous devices that make up this class. § 868.1840 - Diagnostic spirometer. § 868.1850 - Monitoring spirometer.§ 868.1860 - Peak-flow meter for spirometry.§ 868.1870 - Gas volume calibrator. § 868.1880 - Pulmonary-function data calculator.§ 868.1890 - Predictive pulmonary-function value calculator. ...these are just some of the devices that make up the medical supply list in the Anesthesiology category. In the US and other parts of the world Anesthesiology medical supplies are governed by regulatory requirements. The US FDA commissioner receives recommendations from the Anesthesiology and Respiratory Therapy Devices Panel regarding safety and effectiveness of anesthesiology and respiratory therapy medical supplies. Only safe and effective devices make it to the US market. Three regulator pathways are established to get your Anesthesiology medical devices on the US market. For Class II devices, you must submit a premarket notification application For high risk devices the regulatory evaluation method is the PMA (for Class III devices) Class I devices usually do not require US FDA review or approval but do require the manufacturer to list the devices. Medical Supplies, are sometimes marketed using the internet, by stores operated by the distributors or sold by non-US merchants. These medical supplies can be considered harmful since the medical products probably haven't been evaluated by the FDA. Several categories define Anesthesia devices. Besides a Miscellaneous category there are also Diagnostic, Therapeutic and monitoring Anesthesia devices. Diagnostic Anesthesiology Devices consist a subgroup with the following: Carbon dioxide gas analyzer, Carbon monoxide gas analyzer, Enflurane gas analyzer, Gas collection vessel, Diagnostic pulmonary-function interpretation calculator, As an example the following are some of the devices in the Therapeutic group: Heat and moisture condenser (artificial nose), Cuff spreader, Powered percussor, Gas mask head strap, Anesthetic gas mask, Electroanesthesia apparatus, Ether hook, Gas-scavenging apparatus, Portable oxygen generator. The Micellaneous devices include: Calibration gas, Anesthetic cabinet. Monitoring devices include (as a sample): Gas pressure calibrator, Pressure regulator, Electrical peripheral nerve stimulator. More details and a complete list of devices in each of the above categories can be found at the FDA's official website.;>.
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