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FDA 510(k)

MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR

K-Number: K900735 · 1990-05-02

ApplicantPreemicare Corp.
Decision Date1990-05-02
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1990-05-02 under 510(k) number K900735. 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 MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR?

MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR is a medical device that received FDA 510(k) clearance on 1990-05-02. The listed applicant is Preemicare Corp.. The 510(k) number is K900735.

When did MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR receive FDA 510(k) clearance?

MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR received FDA 510(k) clearance on 1990-05-02, under 510(k) number K900735.

Who is the listed applicant for MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR?

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

What is the FDA product code for MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR?

The FDA product code for MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR is FMZ.

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Other records listing Preemicare 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.

K911450INFANT VENTILATORK896375PREEMICARE NEBUTECH NEBULIZER SYSTEMK893622PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.K893624PREEMICARE MODEL 2500 TRANSPORT WARMERK891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 275K885350PREEMICARE SERIES 2000 INFANT 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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