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FDA 510(k)

CAST-TECH CO. COOLING SYSTEM

K-Number: K852495 · 1985-09-05

ApplicantCast-Tech Co.
Decision Date1985-09-05
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CAST-TECH CO. COOLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cast-Tech Co.. It received FDA 510(k) clearance on 1985-09-05 under 510(k) number K852495. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAST-TECH CO. COOLING SYSTEM?

CAST-TECH CO. COOLING SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-05. The listed applicant is Cast-Tech Co.. The 510(k) number is K852495.

When did CAST-TECH CO. COOLING SYSTEM receive FDA 510(k) clearance?

CAST-TECH CO. COOLING SYSTEM received FDA 510(k) clearance on 1985-09-05, under 510(k) number K852495.

Who is the listed applicant for CAST-TECH CO. COOLING SYSTEM?

The FDA 510(k) record lists Cast-Tech Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAST-TECH CO. COOLING SYSTEM?

The FDA product code for CAST-TECH CO. COOLING SYSTEM is ILO.

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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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