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FDA 510(k)

OXYGENAIRE NURING INCUBATOR

K-Number: K813239 · 1982-01-28

ApplicantVickers America Medical Corp.
Decision Date1982-01-28
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OXYGENAIRE NURING INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vickers America Medical Corp.. It received FDA 510(k) clearance on 1982-01-28 under 510(k) number K813239. 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 OXYGENAIRE NURING INCUBATOR?

OXYGENAIRE NURING INCUBATOR is a medical device that received FDA 510(k) clearance on 1982-01-28. The listed applicant is Vickers America Medical Corp.. The 510(k) number is K813239.

When did OXYGENAIRE NURING INCUBATOR receive FDA 510(k) clearance?

OXYGENAIRE NURING INCUBATOR received FDA 510(k) clearance on 1982-01-28, under 510(k) number K813239.

Who is the listed applicant for OXYGENAIRE NURING INCUBATOR?

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

What is the FDA product code for OXYGENAIRE NURING INCUBATOR?

The FDA product code for OXYGENAIRE NURING INCUBATOR is FMZ.

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Other records listing Vickers America 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.

K840823TREONIC C30K831838LABORATORY DATA MGMT SYSTEM SDMSK830748RESUSCITAIREK830936TREONIC IP5K813238NEOCARE BABY-CONTROLLED INCUBATORK811865VMA PEDIATRIC APNEA MATTRESS

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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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