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FDA 510(k)

K-MODULE II HEAT THERAPY SYSTEM

K-Number: K910061 · 1991-02-13

ApplicantBaxter Healthcare Corp
Decision Date1991-02-13
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

K-MODULE II HEAT THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-02-13 under 510(k) number K910061. 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 K-MODULE II HEAT THERAPY SYSTEM?

K-MODULE II HEAT THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1991-02-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K910061.

When did K-MODULE II HEAT THERAPY SYSTEM receive FDA 510(k) clearance?

K-MODULE II HEAT THERAPY SYSTEM received FDA 510(k) clearance on 1991-02-13, under 510(k) number K910061.

Who is the listed applicant for K-MODULE II HEAT THERAPY SYSTEM?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-MODULE II HEAT THERAPY SYSTEM?

The FDA product code for K-MODULE II HEAT THERAPY SYSTEM is ILO.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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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