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FDA 510(k)

MEDIVAC

K-Number: K924577 · 1993-03-23

ApplicantMedisonic U.S.A., Inc.
Decision Date1993-03-23
Product CodeGCX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDIVAC is the device name listed in this FDA 510(k) record. The listed applicant is Medisonic U.S.A., Inc.. It received FDA 510(k) clearance on 1993-03-23 under 510(k) number K924577. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDIVAC?

MEDIVAC is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Medisonic U.S.A., Inc.. The 510(k) number is K924577.

When did MEDIVAC receive FDA 510(k) clearance?

MEDIVAC received FDA 510(k) clearance on 1993-03-23, under 510(k) number K924577.

Who is the listed applicant for MEDIVAC?

The FDA 510(k) record lists Medisonic U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIVAC?

The FDA product code for MEDIVAC is GCX.

Related Clinical Trials

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Other records listing Medisonic U.S.A., 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.

K923660MEDISONIC OXYGEN FLOW CONTROLLERK901114MEDISONIC HUMDIFIER/INHALERK896192MEDISONIC PNEU-NEBK894961MEDISONIC ULTRA-SONIC INHALER

Related Devices (Code: GCX)

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.

K042454STRYKER CASSETTE PUMPStryker EndoscopyK992126CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEMCircon Corp.K972074SUCTION INSTRUMENTATIONWalter Lorenz Surgical, Inc.K971022CHASE SUCKERChase Medical, Inc.K964127MEDI-VAC FLEXI-CLEAR SUCTION HANDLEAllegiance Healthcare Corp.K964519CURITY THORACENTESIS TRAYKendall Healthcare Products Co. Div.Of Tyco Health

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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