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FDA 510(k)

POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE

K-Number: K905697 · 1990-12-27

ApplicantImpact Instrumentation, Inc.
Decision Date1990-12-27
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE 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 1990-12-27 under 510(k) number K905697. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE?

POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE is a medical device that received FDA 510(k) clearance on 1990-12-27. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K905697.

When did POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE receive FDA 510(k) clearance?

POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE received FDA 510(k) clearance on 1990-12-27, under 510(k) number K905697.

Who is the listed applicant for POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE?

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 POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE?

The FDA product code for POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE is BTL.

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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)

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Related Devices (Code: BTL)

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.

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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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