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FDA 510(k)

HOT SACK

K-Number: K921395 · 1992-09-02

ApplicantC.F. Electronics, Inc.
Decision Date1992-09-02
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HOT SACK is the device name listed in this FDA 510(k) record. The listed applicant is C.F. Electronics, Inc.. It received FDA 510(k) clearance on 1992-09-02 under 510(k) number K921395. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOT SACK?

HOT SACK is a medical device that received FDA 510(k) clearance on 1992-09-02. The listed applicant is C.F. Electronics, Inc.. The 510(k) number is K921395.

When did HOT SACK receive FDA 510(k) clearance?

HOT SACK received FDA 510(k) clearance on 1992-09-02, under 510(k) number K921395.

Who is the listed applicant for HOT SACK?

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

What is the FDA product code for HOT SACK?

The FDA product code for HOT SACK is LGZ.

Other records listing C.F. Electronics, 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.

K955659DRUGBOXK926161RES Q AIR SYSTEM MODEL HT-1000K932570MARK I HUMIDIFIERK922786THERM O DRUG MODEL HT-747

Related Devices (Code: LGZ)

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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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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