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FDA 510(k)

KUDO (POWERED ROTATION BED)

K-Number: K905390 · 1991-01-08

ApplicantKinetic Concepts, Inc.
Decision Date1991-01-08
Product CodeIKZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KUDO (POWERED ROTATION BED) 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 1991-01-08 under 510(k) number K905390. The device is classified under product code IKZ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KUDO (POWERED ROTATION BED)?

KUDO (POWERED ROTATION BED) is a medical device that received FDA 510(k) clearance on 1991-01-08. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K905390.

When did KUDO (POWERED ROTATION BED) receive FDA 510(k) clearance?

KUDO (POWERED ROTATION BED) received FDA 510(k) clearance on 1991-01-08, under 510(k) number K905390.

Who is the listed applicant for KUDO (POWERED ROTATION BED)?

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 KUDO (POWERED ROTATION BED)?

The FDA product code for KUDO (POWERED ROTATION BED) is IKZ.

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Other records listing Kinetic Concepts, Inc. as applicant

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Related Devices (Code: IKZ)

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.

K972486PRESSUREGUARD IVSpan-America Medical Systems, Inc.K972111RUMORS DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMGaymar Industries, Inc.K954671THE FREEDOM BEDProbed Medical Technologies, Inc.K950756PULMONEX DYNAMIC AIR THERAPY UNITHill-Rom, Inc.K950681MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPYInvacare Corp.

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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