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FDA 510(k)

HOT/ICE DUAL FUNCTION EQUIPMENT

K-Number: K871962 · 1987-06-26

ApplicantThermo Temp, Inc.
Decision Date1987-06-26
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOT/ICE DUAL FUNCTION EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Temp, Inc.. It received FDA 510(k) clearance on 1987-06-26 under 510(k) number K871962. 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 HOT/ICE DUAL FUNCTION EQUIPMENT?

HOT/ICE DUAL FUNCTION EQUIPMENT is a medical device that received FDA 510(k) clearance on 1987-06-26. The listed applicant is Thermo Temp, Inc.. The 510(k) number is K871962.

When did HOT/ICE DUAL FUNCTION EQUIPMENT receive FDA 510(k) clearance?

HOT/ICE DUAL FUNCTION EQUIPMENT received FDA 510(k) clearance on 1987-06-26, under 510(k) number K871962.

Who is the listed applicant for HOT/ICE DUAL FUNCTION EQUIPMENT?

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

What is the FDA product code for HOT/ICE DUAL FUNCTION EQUIPMENT?

The FDA product code for HOT/ICE DUAL FUNCTION EQUIPMENT 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 Thermo Temp, 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.

K871963HOT/ICE DISPOSABLE BLANKETK833564HOT/ICE DISPOSABLE BLANKETK830757HOT/ICE

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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