FDA 510(k)

COLD ROLL

K-Number: K820901 · 1982-04-15

Decision Date1982-04-15

Product CodeIME

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

COLD ROLL is the device name listed in this FDA 510(k) record. The listed applicant is North Bank Labs, Inc.. It received FDA 510(k) clearance on 1982-04-15 under 510(k) number K820901. 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 ROLL?

COLD ROLL is a medical device that received FDA 510(k) clearance on 1982-04-15. The listed applicant is North Bank Labs, Inc.. The 510(k) number is K820901.

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

COLD ROLL received FDA 510(k) clearance on 1982-04-15, under 510(k) number K820901.

Who is the listed applicant for COLD ROLL?

The FDA 510(k) record lists North Bank Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLD ROLL?

The FDA product code for COLD ROLL 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.

K923627COLD PACKFriendmed Products K915876HOTPADTen Comfort Corp.K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.K882413SUBOCCIPITAL ICE PILLOWFerguson Medical K863654RE-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.