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FDA 510(k)

UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+

K-Number: K091238 · 2009-08-13

ApplicantImpact Instrumentation, Inc.
Decision Date2009-08-13
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ 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 2009-08-13 under 510(k) number K091238. 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-731 SERIES VENTILATORS, MODEL 731EMV+?

UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K091238.

When did UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ receive FDA 510(k) clearance?

UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ received FDA 510(k) clearance on 2009-08-13, under 510(k) number K091238.

Who is the listed applicant for UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+?

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-731 SERIES VENTILATORS, MODEL 731EMV+?

The FDA product code for UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ 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 VENTILATORK071526UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMVK051476UNI-VENT MODEL 73XK032386UNI-VENT MODEL 730AEV (AUTOMATIC EMERGENCY VENTILATOR)K022062IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

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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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