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FDA 510(k)

THERMA-SHIELD

K-Number: K801461 · 1980-07-28

ApplicantOlympic Medical Corp.
Decision Date1980-07-28
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMA-SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Medical Corp.. It received FDA 510(k) clearance on 1980-07-28 under 510(k) number K801461. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMA-SHIELD?

THERMA-SHIELD is a medical device that received FDA 510(k) clearance on 1980-07-28. The listed applicant is Olympic Medical Corp.. The 510(k) number is K801461.

When did THERMA-SHIELD receive FDA 510(k) clearance?

THERMA-SHIELD received FDA 510(k) clearance on 1980-07-28, under 510(k) number K801461.

Who is the listed applicant for THERMA-SHIELD?

The FDA 510(k) record lists Olympic Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMA-SHIELD?

The FDA product code for THERMA-SHIELD is FMZ.

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Other records listing Olympic Medical Corp. 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.

K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500K031149OLYMPIC CFM 6000K020335OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330K001056OLYMPIC WARM-UPK983229OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMK971601OLYMPIC BILI-BASSINET

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Related Devices (Code: FMZ)

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.

K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)Datex-Ohmeda, Inc.K251619Babyleo TN500Drägerwerk AG & Co. KGaAK251663Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1)Datex-Ohmeda, Inc.K243437mOm Essential Incubator (ME1)Mom Incubators LimitedK213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.K190494Infant IncubatorNingbo David Medical Device Co., Ltd.

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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