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FDA 510(k)

COOL 'N HEAT MACHINE

K-Number: K891151 · 1989-04-06

ApplicantKinetic Concepts, Inc.
Decision Date1989-04-06
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COOL 'N HEAT 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 1989-04-06 under 510(k) number K891151. 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 COOL 'N HEAT MACHINE?

COOL 'N HEAT MACHINE is a medical device that received FDA 510(k) clearance on 1989-04-06. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K891151.

When did COOL 'N HEAT MACHINE receive FDA 510(k) clearance?

COOL 'N HEAT MACHINE received FDA 510(k) clearance on 1989-04-06, under 510(k) number K891151.

Who is the listed applicant for COOL 'N HEAT 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 COOL 'N HEAT MACHINE?

The FDA product code for COOL 'N HEAT MACHINE is 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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