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FDA 510(k)

HOT/ICE DISPOSABLE BLANKET

K-Number: K833564 · 1983-11-28

ApplicantThermo Temp, Inc.
Decision Date1983-11-28
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HOT/ICE DISPOSABLE BLANKET 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 1983-11-28 under 510(k) number K833564. 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 DISPOSABLE BLANKET?

HOT/ICE DISPOSABLE BLANKET is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Thermo Temp, Inc.. The 510(k) number is K833564.

When did HOT/ICE DISPOSABLE BLANKET receive FDA 510(k) clearance?

HOT/ICE DISPOSABLE BLANKET received FDA 510(k) clearance on 1983-11-28, under 510(k) number K833564.

Who is the listed applicant for HOT/ICE DISPOSABLE BLANKET?

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 DISPOSABLE BLANKET?

The FDA product code for HOT/ICE DISPOSABLE BLANKET 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.

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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 BLANKETK871962HOT/ICE DUAL FUNCTION EQUIPMENTK830757HOT/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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