FDA 510(k)

HOT/ICE

K-Number: K830757 · 1983-03-29

Decision Date1983-03-29

Product CodeILO

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

HOT/ICE 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 1983-03-29 under 510(k) number K830757. 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?

HOT/ICE is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Thermo Temp, Inc.. The 510(k) number is K830757.

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

HOT/ICE received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830757.

Who is the listed applicant for HOT/ICE?

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?

The FDA product code for HOT/ICE is ILO.

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 BLANKET K871962HOT/ICE DUAL FUNCTION EQUIPMENT K833564HOT/ICE DISPOSABLE BLANKET

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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.