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FDA 510(k)

COLD PACK #589

K-Number: K801776 · 1980-08-07

ApplicantSunbeam Corp.
Decision Date1980-08-07
Product CodeIME
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COLD PACK #589 is the device name listed in this FDA 510(k) record. The listed applicant is Sunbeam Corp.. It received FDA 510(k) clearance on 1980-08-07 under 510(k) number K801776. 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 #589?

COLD PACK #589 is a medical device that received FDA 510(k) clearance on 1980-08-07. The listed applicant is Sunbeam Corp.. The 510(k) number is K801776.

When did COLD PACK #589 receive FDA 510(k) clearance?

COLD PACK #589 received FDA 510(k) clearance on 1980-08-07, under 510(k) number K801776.

Who is the listed applicant for COLD PACK #589?

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

What is the FDA product code for COLD PACK #589?

The FDA product code for COLD PACK #589 is IME.

Other records listing Sunbeam Corp. 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.

K842275ULTRASONIC COOL SPRAY HUMIDIFIERK780360MASSAGER, GUM/SSAGE POWERED GUM

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.

K923627COLD PACKFriendmed ProductsK915876HOTPADTen 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.

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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