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NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL;
K-NUMBER: K992133;
APPLICANT: NEWPORT MEDICAL INSTRUMENTS, INC.;
CONTACT: ROBERT W DICK;
ADDRESS: 760 WEST 16TH ST., BLDG. N;, ;, COSTA MESA;, CA;, 92627;
DATE RECEIVED: 23/06/1999;
DECISION DATE: 04/08/2000;
REVIEW ADVISORY BOARD: AN;
MEDICAL SPECIALTY: ANAESTHESIA
PRODUCT CODE: CBK;
TYPE OF SUBMISSION: Traditional;
CLASSIFICATION OF DEVICE: Class 2;
: ;
DEFINITION: ;
TECHNICAL METHOD: ;
TARGET AREA: ;
Medical supply for Anesthesiology is comprised of many devices Some of the medical supplies that make up the class include: § 868.1030 - Manual algesimeter,§ 868.1040 - Powered algesimeter.,§ 868.1075 - Argon gas analyzer.§ 868.1100 - Arterial blood sampling kit.,§ 868.1120 - Indwelling blood oxyhemoglobin concentration analyzer. In the US and other parts of the world Anesthesiology medical supplies are governed by regulatory requirements. The Anesthesiology and Respiratory Therapy Devices Panel forward recommendations based on review and evaluation of safety and effectiveness data related to anesthesiology and respiratory therapy medical supplies - to the US FDA commissioner. Medical Supplies must meet certain criteria. Essentially three regulatory mechanisms are established to get your Anesthesiology medical device on the US market. For medium risk devices the method is via 510(k). This is reserved for Class II devices. There are the highest risk (Class III) devices that require premarket approval. Device listing is required for low (class I) medical devices. Medical Devices can be marketed local distributor using the internet directly by distributors or sold directly to consumers from outside of the country. These medical supplies may be adulterated since the products potentially not review by the Food and Drug Agency. There are three main classes of Anesthesia devices and one Miscellaneous one. They are Diagnostic Devices, Monitoring Devices, Therapeutic Devices and a Miscellaneous category. The Anesthesiology Diagnostic devices include (just as a sampling): Indwelling blood hydrogen ion concentration (pH) analyzer, Indwelling blood oxygen partial pressure (PO2) analyzer, Predictive pulmonary-function value calculator, Devices in the Therapeutic group include: 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. A sampling of Micellaneous Anesthesiology Devices includes: Nose clip, Portable air compressor, Calibration gas. Monitoring products include (a sample): Lung water monitor, Cutaneous carbon dioxide (PcCO[bdi2]) monitor, Cutaneous oxygen (PcO[bdi2]) monitor. For more devices in the above listed categories please visit the FDA's website.;>.
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