VOCSN Unified Respiratory System

Ventilator, Continuous, Facility Use

VENTEC LIFE SYSTEMS, INC

The following data is part of a premarket notification filed by Ventec Life Systems, Inc with the FDA for Vocsn Unified Respiratory System.

Pre-market Notification Details

• Device ID: K162877
• 510k Number: K162877
• Device Name: VOCSN Unified Respiratory System
• Classification: Ventilator, Continuous, Facility Use
• Applicant: VENTEC LIFE SYSTEMS, INC 19021 120TH AVE NE SUITE 101 Bothell, WA 98011
• Contact: Joseph Cipollone
• Correspondent: Joseph Cipollone; VENTEC LIFE SYSTEMS, INC 19021 120TH AVE NE SUITE 101 Bothell, WA 98011
• Product Code: CBK
• Subsequent Product Code: BTA
• Subsequent Product Code: BZE
• Subsequent Product Code: CAH
• Subsequent Product Code: CAW
• Subsequent Product Code: NHJ
• Subsequent Product Code: NOU
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-14
• Decision Date: 2017-04-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00855573007822	K162877	000
00855573007945	K162877	000
00855573007204	K162877	000
00855573007211	K162877	000
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00855573007747	K162877	000
00855573007778	K162877	000
00855573007792	K162877	000
00855573007815	K162877	000
00855573007006	K162877	000
00855573007198	K162877	000
00855573007020	K162877	000
00855573007242	K162877	000
00855573007280	K162877	000
00855573007051	K162877	000
00855573007907	K162877	000
00855573007877	K162877	000
00855573007761	K162877	000
00855573007785	K162877	000
00850018761178	K162877	000
00850018761154	K162877	000
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00850018761130	K162877	000
00850018761123	K162877	000
00850018761055	K162877	000
00850018761079	K162877	000
00855573007891	K162877	000
00855573007938	K162877	000
00855573007532	K162877	000
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00855573007860	K162877	000
00855573007068	K162877	000
00855573007310	K162877	000
00855573007433	K162877	000
00855573007440	K162877	000
00855573007464	K162877	000
00855573007471	K162877	000
00855573007488	K162877	000
00855573007556	K162877	000
00855573007570	K162877	000
00855573007594	K162877	000
00855573007617	K162877	000
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00855573007174	K162877	000
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00855573007266	K162877	000
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00855573007389	K162877	000
00855573007396	K162877	000
00855573007402	K162877	000
00855573007716	K162877	000