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FDA 510(k)

GOLDEN THERMAL(R)

K-Number: K914182 · 1991-10-18

ApplicantSeabrook Medical Systems, Inc.
Decision Date1991-10-18
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GOLDEN THERMAL(R) is the device name listed in this FDA 510(k) record. The listed applicant is Seabrook Medical Systems, Inc.. It received FDA 510(k) clearance on 1991-10-18 under 510(k) number K914182. 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 GOLDEN THERMAL(R)?

GOLDEN THERMAL(R) is a medical device that received FDA 510(k) clearance on 1991-10-18. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K914182.

When did GOLDEN THERMAL(R) receive FDA 510(k) clearance?

GOLDEN THERMAL(R) received FDA 510(k) clearance on 1991-10-18, under 510(k) number K914182.

Who is the listed applicant for GOLDEN THERMAL(R)?

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

What is the FDA product code for GOLDEN THERMAL(R)?

The FDA product code for GOLDEN THERMAL(R) is ILO.

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Other records listing Seabrook Medical Systems, 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.

K946196TROPICAIR CONVECTIVE WARING SYSTEMK952086TROPICAIR CONVECTIVE WARMING BLANKETSK931203COOL-AIDK923104TROPIC-AIRK902756TROPI-COOLK902269ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY

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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.

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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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