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FDA 510(k)

IMPACT 901 SERIES PORT-A-WALL

K-Number: K850671 · 1985-03-11

ApplicantImpact Instrumentation, Inc.
Decision Date1985-03-11
Product CodeFOX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMPACT 901 SERIES PORT-A-WALL 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 1985-03-11 under 510(k) number K850671. The device is classified under product code FOX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPACT 901 SERIES PORT-A-WALL?

IMPACT 901 SERIES PORT-A-WALL is a medical device that received FDA 510(k) clearance on 1985-03-11. The listed applicant is Impact Instrumentation, Inc.. The 510(k) number is K850671.

When did IMPACT 901 SERIES PORT-A-WALL receive FDA 510(k) clearance?

IMPACT 901 SERIES PORT-A-WALL received FDA 510(k) clearance on 1985-03-11, under 510(k) number K850671.

Who is the listed applicant for IMPACT 901 SERIES PORT-A-WALL?

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 IMPACT 901 SERIES PORT-A-WALL?

The FDA product code for IMPACT 901 SERIES PORT-A-WALL is FOX.

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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: FOX)

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.

K980336IV STANDSClinton Industries, Inc.K964782MEDRAD CONTRAST HOLDERMedrad, Inc.K961470PORT-A-POLEPrins Medical Ind., Inc.K960027HIGH VOLUME I.V. & IRRIGATION TOWERAllen Medical Systems, Inc.K952196IV POLE/STANDValentine Intl. , Ltd.K950367IV SHUTTLEEquipment Concepts, Inc.

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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