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FDA 510(k)

MEDI-THERM (MTA-5900) & DETACHABLE HOSES

K-Number: K912051 · 1991-07-30

ApplicantGaymar Industries, Inc.
Decision Date1991-07-30
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-THERM (MTA-5900) & DETACHABLE HOSES 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 1991-07-30 under 510(k) number K912051. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-THERM (MTA-5900) & DETACHABLE HOSES?

MEDI-THERM (MTA-5900) & DETACHABLE HOSES is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is Gaymar Industries, Inc.. The 510(k) number is K912051.

When did MEDI-THERM (MTA-5900) & DETACHABLE HOSES receive FDA 510(k) clearance?

MEDI-THERM (MTA-5900) & DETACHABLE HOSES received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912051.

Who is the listed applicant for MEDI-THERM (MTA-5900) & DETACHABLE HOSES?

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 MEDI-THERM (MTA-5900) & DETACHABLE HOSES?

The FDA product code for MEDI-THERM (MTA-5900) & DETACHABLE HOSES is DWJ.

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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: DWJ)

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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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