AMADEUS ADAPTIVE COMPRESSION THERAPY

Sleeve, Limb, Compressible

CONVATEC

The following data is part of a premarket notification filed by Convatec with the FDA for Amadeus Adaptive Compression Therapy.

Pre-market Notification Details

• Device ID: K071763
• 510k Number: K071763
• Device Name: AMADEUS ADAPTIVE COMPRESSION THERAPY
• Classification: Sleeve, Limb, Compressible
• Applicant: CONVATEC 200 HEADQUARTERS PARK DR. Skillman, NJ 08558
• Contact: Marilyn Konicky
• Correspondent: Marilyn Konicky; CONVATEC 200 HEADQUARTERS PARK DR. Skillman, NJ 08558
• Product Code: JOW
• CFR Regulation Number: 870.5800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-29
• Decision Date: 2008-03-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816305020694	K071763	000
00816305020885	K071763	000
00816305020892	K071763	000
00816305020908	K071763	000
00816305020915	K071763	000
00816305020922	K071763	000
00816305020939	K071763	000
00816305020946	K071763	000
00816305020953	K071763	000
00816305021103	K071763	000
00816305021110	K071763	000
00816305021127	K071763	000
00816305021134	K071763	000
00816305021417	K071763	000
00816305021424	K071763	000
00816305021431	K071763	000
00816305020878	K071763	000
00816305020861	K071763	000
00816305020854	K071763	000
00816305020700	K071763	000
00816305020717	K071763	000
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00816305020755	K071763	000
00816305020762	K071763	000
00816305020779	K071763	000
00816305020786	K071763	000
00816305020793	K071763	000
00816305020809	K071763	000
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00816305023145	K071763	000
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00816305023176	K071763	000
00816305023183	K071763	000
00816305023190	K071763	000
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00816305022995	K071763	000
00816305023008	K071763	000
00816305023015	K071763	000
00816305023022	K071763	000
00816305023039	K071763	000
00816305023046	K071763	000
00816305023053	K071763	000
00816305023060	K071763	000
00816305023077	K071763	000
00816305023091	K071763	000
00816305023367	K071763	000