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FDA 510(k)

AMEDA AMECARE(R) NEONATAL INCUBATOR

K-Number: K870222 · 1987-06-10

ApplicantHollister, Inc.
Decision Date1987-06-10
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMEDA AMECARE(R) NEONATAL INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Hollister, Inc.. It received FDA 510(k) clearance on 1987-06-10 under 510(k) number K870222. 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 AMEDA AMECARE(R) NEONATAL INCUBATOR?

AMEDA AMECARE(R) NEONATAL INCUBATOR is a medical device that received FDA 510(k) clearance on 1987-06-10. The listed applicant is Hollister, Inc.. The 510(k) number is K870222.

When did AMEDA AMECARE(R) NEONATAL INCUBATOR receive FDA 510(k) clearance?

AMEDA AMECARE(R) NEONATAL INCUBATOR received FDA 510(k) clearance on 1987-06-10, under 510(k) number K870222.

Who is the listed applicant for AMEDA AMECARE(R) NEONATAL INCUBATOR?

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

What is the FDA product code for AMEDA AMECARE(R) NEONATAL INCUBATOR?

The FDA product code for AMEDA AMECARE(R) NEONATAL INCUBATOR is FMZ.

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Other records listing Hollister, Inc. as applicant

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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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