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FDA 510(k)

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT

K-Number: K891091 · 1990-03-26

ApplicantTemptek, Inc.
Decision Date1990-03-26
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Temptek, Inc.. It received FDA 510(k) clearance on 1990-03-26 under 510(k) number K891091. 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 TEMPTEK T-1000 THERAPEUTIC COOLING UNIT?

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT is a medical device that received FDA 510(k) clearance on 1990-03-26. The listed applicant is Temptek, Inc.. The 510(k) number is K891091.

When did TEMPTEK T-1000 THERAPEUTIC COOLING UNIT receive FDA 510(k) clearance?

TEMPTEK T-1000 THERAPEUTIC COOLING UNIT received FDA 510(k) clearance on 1990-03-26, under 510(k) number K891091.

Who is the listed applicant for TEMPTEK T-1000 THERAPEUTIC COOLING UNIT?

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

What is the FDA product code for TEMPTEK T-1000 THERAPEUTIC COOLING UNIT?

The FDA product code for TEMPTEK T-1000 THERAPEUTIC COOLING UNIT is ILO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Temptek, 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.

K945468T-300 COOLERK891092TEMPTEK 5010 THERMAL COOLING BLANKET

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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