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FDA 510(k)

GRAND COOLING MACHINE

K-Number: K891152 · 1989-03-23

ApplicantKinetic Concepts, Inc.
Decision Date1989-03-23
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GRAND COOLING MACHINE 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 1989-03-23 under 510(k) number K891152. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRAND COOLING MACHINE?

GRAND COOLING MACHINE is a medical device that received FDA 510(k) clearance on 1989-03-23. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K891152.

When did GRAND COOLING MACHINE receive FDA 510(k) clearance?

GRAND COOLING MACHINE received FDA 510(k) clearance on 1989-03-23, under 510(k) number K891152.

Who is the listed applicant for GRAND COOLING MACHINE?

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 GRAND COOLING MACHINE?

The FDA product code for GRAND COOLING MACHINE is ILO.

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Other records listing Kinetic Concepts, Inc. as applicant

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Related Devices (Code: ILO)

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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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