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FDA 510(k)

COLD PACK

K-Number: K923627 · 1993-04-14

ApplicantFriendmed Products
Decision Date1993-04-14
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD PACK is the device name listed in this FDA 510(k) record. The listed applicant is Friendmed Products. It received FDA 510(k) clearance on 1993-04-14 under 510(k) number K923627. The device is classified under product code IME. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLD PACK?

COLD PACK is a medical device that received FDA 510(k) clearance on 1993-04-14. The listed applicant is Friendmed Products. The 510(k) number is K923627.

When did COLD PACK receive FDA 510(k) clearance?

COLD PACK received FDA 510(k) clearance on 1993-04-14, under 510(k) number K923627.

Who is the listed applicant for COLD PACK?

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

What is the FDA product code for COLD PACK?

The FDA product code for COLD PACK is IME.

Related Devices (Code: IME)

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.

K915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson MedicalK863654RE-HEATER, HOT PACKK & L Ent.K832193NICE PACKUniversal Medical Instrument Corp.

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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