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FDA 510(k)

T-PUMP, TEMPERATURE - THERAPY PUMP

K-Number: K760804 · 1976-10-15

ApplicantGaymar Industries, Inc.
Decision Date1976-10-15
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

T-PUMP, TEMPERATURE - THERAPY PUMP is the device name listed in this FDA 510(k) record. The listed applicant is Gaymar Industries, Inc.. It received FDA 510(k) clearance on 1976-10-15 under 510(k) number K760804. 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 T-PUMP, TEMPERATURE - THERAPY PUMP?

T-PUMP, TEMPERATURE - THERAPY PUMP is a medical device that received FDA 510(k) clearance on 1976-10-15. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K760804.

When did T-PUMP, TEMPERATURE - THERAPY PUMP receive FDA 510(k) clearance?

T-PUMP, TEMPERATURE - THERAPY PUMP received FDA 510(k) clearance on 1976-10-15, under 510(k) number K760804.

Who is the listed applicant for T-PUMP, TEMPERATURE - THERAPY PUMP?

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

What is the FDA product code for T-PUMP, TEMPERATURE - THERAPY PUMP?

The FDA product code for T-PUMP, TEMPERATURE - THERAPY PUMP is ILO.

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Other records listing Gaymar Industries, 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.

K100585MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPK962788CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEMK963067SOF. PRESS EPC 51 SYSTEMK961854SPR PLUS II OVERLAY SYSTEM (CL250/CL212K942881TC 3000

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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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