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FDA 510(k)

THERMOTEK H-300

K-Number: K945853 · 1995-10-05

ApplicantThermotek, Inc.
Decision Date1995-10-05
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

THERMOTEK H-300 is the device name listed in this FDA 510(k) record. The listed applicant is Thermotek, Inc.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K945853. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the THERMOTEK H-300?

THERMOTEK H-300 is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Thermotek, Inc.. The 510(k) number is K945853.

When did THERMOTEK H-300 receive FDA 510(k) clearance?

THERMOTEK H-300 received FDA 510(k) clearance on 1995-10-05, under 510(k) number K945853.

Who is the listed applicant for THERMOTEK H-300?

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

What is the FDA product code for THERMOTEK H-300?

The FDA product code for THERMOTEK H-300 is ILO.

Related Clinical Trials

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Other records listing Thermotek, Inc. as applicant

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.

K103247VASCUCOMPK061866NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPSK950711T-350 THERAPEUTIC COOLING MACHINE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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