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FDA 510(k)

MICROAIR 3500

K-Number: K914674 · 1991-11-22

ApplicantGsi Development Co.
Decision Date1991-11-22
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MICROAIR 3500 is the device name listed in this FDA 510(k) record. The listed applicant is Gsi Development Co.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914674. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROAIR 3500?

MICROAIR 3500 is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Gsi Development Co.. The 510(k) number is K914674.

When did MICROAIR 3500 receive FDA 510(k) clearance?

MICROAIR 3500 received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914674.

Who is the listed applicant for MICROAIR 3500?

The FDA 510(k) record lists Gsi Development Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROAIR 3500?

The FDA product code for MICROAIR 3500 is IOQ.

Related Clinical Trials

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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Other records listing Gsi Development Co. 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.

K926456MICROAIR TURN-QK893708FLUIDIZED AIR BEDK884529MICROAIR FLUIDIZED AIR BED

Related Devices (Code: IOQ)

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.

K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-RomK973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist ProductsK970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, 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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