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FDA 510(k)

OHMEDA-OHIO CARE PLUS INCUBATOR

K-Number: K974349 · 1998-02-12

ApplicantOhmeda Medical
Decision Date1998-02-12
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OHMEDA-OHIO CARE PLUS INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Ohmeda Medical. It received FDA 510(k) clearance on 1998-02-12 under 510(k) number K974349. 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 OHMEDA-OHIO CARE PLUS INCUBATOR?

OHMEDA-OHIO CARE PLUS INCUBATOR is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Ohmeda Medical. The 510(k) number is K974349.

When did OHMEDA-OHIO CARE PLUS INCUBATOR receive FDA 510(k) clearance?

OHMEDA-OHIO CARE PLUS INCUBATOR received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974349.

Who is the listed applicant for OHMEDA-OHIO CARE PLUS INCUBATOR?

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

What is the FDA product code for OHMEDA-OHIO CARE PLUS INCUBATOR?

The FDA product code for OHMEDA-OHIO CARE PLUS INCUBATOR is FMZ.

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Other records listing Ohmeda Medical as applicant

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K123309GIRAFFE AND PANDA WARMERSK101788GIRAFFE OMNIBEDK101778GIRAFFE INCUBATORK090697MODIFICATION TO: GIRAFFE AND PANDA WARMERK072157MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)K070377GIRAFFE AND PANDA WARMER

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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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