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
00850018761413	K162877	000
00855573007907	K162877	000
00855573007945	K162877	000
00855573007204	K162877	000
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00855573007792	K162877	000
00855573007815	K162877	000
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00855573007020	K162877	000
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00855573007877	K162877	000
00855573007860	K162877	000
00855573007501	K162877	000
00850018761383	K162877	000
00855573007822	K162877	000
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00850018761178	K162877	000
00850018761154	K162877	000
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00850018761130	K162877	000
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00850018761055	K162877	000
00850018761079	K162877	000
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00855573007532	K162877	000
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00855573007556	K162877	000
00855573007570	K162877	000
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00855573007389	K162877	000
00855573007396	K162877	000
00855573007716	K162877	000