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FDA 510(k)

OHMEDA - OHIO(R) CARE PLUS INCUBATOR

K-Number: K901585 · 1990-06-22

ApplicantOhmeda Medical
Decision Date1990-06-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OHMEDA - OHIO(R) 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 1990-06-22 under 510(k) number K901585. 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(R) CARE PLUS INCUBATOR?

OHMEDA - OHIO(R) CARE PLUS INCUBATOR is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Ohmeda Medical. The 510(k) number is K901585.

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

OHMEDA - OHIO(R) CARE PLUS INCUBATOR received FDA 510(k) clearance on 1990-06-22, under 510(k) number K901585.

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

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

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Other records listing Ohmeda Medical 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.

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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