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FDA 510(k)

TOTALLY COOL(TM) TC-2

K-Number: K942882 · 1995-02-09

ApplicantElectro Science Technologies, Inc.
Decision Date1995-02-09
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent for Some Indications

Device Summary

TOTALLY COOL(TM) TC-2 is the device name listed in this FDA 510(k) record. The listed applicant is Electro Science Technologies, Inc.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K942882. 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 TOTALLY COOL(TM) TC-2?

TOTALLY COOL(TM) TC-2 is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Electro Science Technologies, Inc.. The 510(k) number is K942882.

When did TOTALLY COOL(TM) TC-2 receive FDA 510(k) clearance?

TOTALLY COOL(TM) TC-2 received FDA 510(k) clearance on 1995-02-09, under 510(k) number K942882.

Who is the listed applicant for TOTALLY COOL(TM) TC-2?

The FDA 510(k) record lists Electro Science Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTALLY COOL(TM) TC-2?

The FDA product code for TOTALLY COOL(TM) TC-2 is ILO.

Related Clinical Trials

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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Other records listing Electro Science Technologies, 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.

K943844TOTALLY COOL(TM) TC-1

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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