UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR

Ventilator, Continuous, Facility Use

IMPACT INSTRUMENTATION, INC.

The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Uni-vent (r) Model 731 Series Portable Critical Care Ventilator.

Pre-market Notification Details

• Device ID: K111473
• 510k Number: K111473
• Device Name: UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR
• Classification: Ventilator, Continuous, Facility Use
• Applicant: IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. West Caldwell, NJ 07006 -0508
• Contact: Susan Mcnevin
• Correspondent: Susan Mcnevin; IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. West Caldwell, NJ 07006 -0508
• Product Code: CBK
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-27
• Decision Date: 2012-02-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10847946023130	K111473	000
00847946026592	K111473	000
20847946023137	K111473	000
20847946023182	K111473	000
00847946020569	K111473	000
00847946020576	K111473	000
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00847946020637	K111473	000
00847946020644	K111473	000
00847946020651	K111473	000
00847946020668	K111473	000
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00847946020699	K111473	000
00847946020897	K111473	000
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00847946029425	K111473	000
00847946029418	K111473	000
00847946029319	K111473	000
10847946023123	K111473	000
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10847946023154	K111473	000
10847946023161	K111473	000
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10847946023185	K111473	000
10847946023192	K111473	000
10847946023208	K111473	000
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00847946023430	K111473	000
00847946023454	K111473	000
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10847946023215	K111473	000
00847946020910	K111473	000
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00847946023423	K111473	000
00847946023447	K111473	000
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00847946023478	K111473	000
00847946023485	K111473	000
00847946023508	K111473	000
00847946024178	K111473	000
00847946024192	K111473	000
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00847946023164	K111473	000
00847946023171	K111473	000
00847946023188	K111473	000
00847946023195	K111473	000
00847946023201	K111473	000
00847946099039	K111473	000