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FDA 510(k)

UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR

K-Number: K870861 · 1988-01-19

ApplicantImpact Instrumentation, Inc.
Decision Date1988-01-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Impact Instrumentation, Inc.. It received FDA 510(k) clearance on 1988-01-19 under 510(k) number K870861. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR?

UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K870861.

When did UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR receive FDA 510(k) clearance?

UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR received FDA 510(k) clearance on 1988-01-19, under 510(k) number K870861.

Who is the listed applicant for UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR?

The FDA 510(k) record lists Impact Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR?

The FDA product code for UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR is CBK.

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Other records listing Impact Instrumentation, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111473UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATORK103318UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATORK091238UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+K071526UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMVK051476UNI-VENT MODEL 73XK032386UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)

View all 26 devices →

Related Devices (Code: CBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253647Evita (V800); Evita (V600)Draegerwerk AG & CO KgaaK252663Inbentus VersatileIconic Solutions by Murcia, SLK251888VPAP Pediatric Face MaskHsiner Co., Ltd.K232365Vivo 45 LSOconnell Regulatory Consultants, Inc.K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented FullFisher & Paykel Healthcare, Ltd.K243767SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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