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FDA 510(k)

DR KOOL

K-Number: K935841 · 1994-08-29

ApplicantToronto Medical Corp.
Decision Date1994-08-29
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

DR KOOL is the device name listed in this FDA 510(k) record. The listed applicant is Toronto Medical Corp.. It received FDA 510(k) clearance on 1994-08-29 under 510(k) number K935841. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the DR KOOL?

DR KOOL is a medical device that received FDA 510(k) clearance on 1994-08-29. The listed applicant is Toronto Medical Corp.. The 510(k) number is K935841.

When did DR KOOL receive FDA 510(k) clearance?

DR KOOL received FDA 510(k) clearance on 1994-08-29, under 510(k) number K935841.

Who is the listed applicant for DR KOOL?

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

What is the FDA product code for DR KOOL?

The FDA product code for DR KOOL is ILO.

Other records listing Toronto Medical 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.

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Related Devices (Code: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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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