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FDA 510(k)

ROTATION AIR FLUIDIZED BED/DELTA

K-Number: K864232 · 1986-12-16

ApplicantKinetic Concepts, Inc.
Decision Date1986-12-16
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ROTATION AIR FLUIDIZED BED/DELTA is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1986-12-16 under 510(k) number K864232. 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 ROTATION AIR FLUIDIZED BED/DELTA?

ROTATION AIR FLUIDIZED BED/DELTA is a medical device that received FDA 510(k) clearance on 1986-12-16. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K864232.

When did ROTATION AIR FLUIDIZED BED/DELTA receive FDA 510(k) clearance?

ROTATION AIR FLUIDIZED BED/DELTA received FDA 510(k) clearance on 1986-12-16, under 510(k) number K864232.

Who is the listed applicant for ROTATION AIR FLUIDIZED BED/DELTA?

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

What is the FDA product code for ROTATION AIR FLUIDIZED BED/DELTA?

The FDA product code for ROTATION AIR FLUIDIZED BED/DELTA is IOQ.

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Other records listing Kinetic Concepts, Inc. as applicant

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K050261V.A.C. GRANUFOAM SILVER PROTECTION DRESSINGK041642V.A.C. GRANUFOAM SILVER DRESSINGK032310MINI V.A.C., V.A.C. FREEDOM, V.A.C. ATSK022011V.A.C. ABDOMINAL DRESSINGK021500VACUUM ASSISTED CLOSUREK021501V.A.C. INSTILLAMAT (VACUUM ASSISTED CLOSURE INSTILLAMAT

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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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