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FDA 510(k)

OLYMPIC WARM-BASSINET

K-Number: K954216 · 1995-12-08

ApplicantOlympic Medical Corp.
Decision Date1995-12-08
Product CodeFOH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OLYMPIC WARM-BASSINET 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 1995-12-08 under 510(k) number K954216. The device is classified under product code FOH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC WARM-BASSINET?

OLYMPIC WARM-BASSINET is a medical device that received FDA 510(k) clearance on 1995-12-08. The listed applicant is Olympic Medical Corp.. The 510(k) number is K954216.

When did OLYMPIC WARM-BASSINET receive FDA 510(k) clearance?

OLYMPIC WARM-BASSINET received FDA 510(k) clearance on 1995-12-08, under 510(k) number K954216.

Who is the listed applicant for OLYMPIC WARM-BASSINET?

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 OLYMPIC WARM-BASSINET?

The FDA product code for OLYMPIC WARM-BASSINET is FOH.

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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: FOH)

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.

K872876IMSI/EASY FLOAT MATTRESSIntl. Management Services, Inc.K812683NEONATE FLEXFLOATPharmaquest Corp.K812684ADULT FLEXFLOATPharmaquest Corp.K812682FLEXFLOAT HEATERPharmaquest Corp.K812681ADULT FLEX FLOAT W/HEATERPharmaquest Corp.

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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