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FDA 510(k)

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS

K-Number: K882229 · 1988-08-16

ApplicantBiologics Intl., Inc.
Decision Date1988-08-16
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Biologics Intl., Inc.. It received FDA 510(k) clearance on 1988-08-16 under 510(k) number K882229. 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 AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS?

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS is a medical device that received FDA 510(k) clearance on 1988-08-16. The listed applicant is Biologics Intl., Inc.. The 510(k) number is K882229.

When did AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS receive FDA 510(k) clearance?

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS received FDA 510(k) clearance on 1988-08-16, under 510(k) number K882229.

Who is the listed applicant for AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS?

The FDA 510(k) record lists Biologics Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS?

The FDA product code for AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS is IOQ.

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Other records listing Biologics Intl., 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.

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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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