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FDA 510(k)

PREEMICARE SERIES 2000 INFANT WARMER

K-Number: K885350 · 1989-08-07

ApplicantPreemicare Corp.
Decision Date1989-08-07
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREEMICARE SERIES 2000 INFANT WARMER is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1989-08-07 under 510(k) number K885350. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREEMICARE SERIES 2000 INFANT WARMER?

PREEMICARE SERIES 2000 INFANT WARMER is a medical device that received FDA 510(k) clearance on 1989-08-07. The listed applicant is Preemicare Corp.. The 510(k) number is K885350.

When did PREEMICARE SERIES 2000 INFANT WARMER receive FDA 510(k) clearance?

PREEMICARE SERIES 2000 INFANT WARMER received FDA 510(k) clearance on 1989-08-07, under 510(k) number K885350.

Who is the listed applicant for PREEMICARE SERIES 2000 INFANT WARMER?

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 PREEMICARE SERIES 2000 INFANT WARMER?

The FDA product code for PREEMICARE SERIES 2000 INFANT WARMER is FMT.

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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 SYSTEMK900735MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATORK893622PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.K893624PREEMICARE MODEL 2500 TRANSPORT WARMERK891674NEONATAL ENVIRONMENTAL MONITOR, MODEL 275

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Related Devices (Code: FMT)

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K243606Babyroo TN300Draeger Medical Systems, Inc.K230278Babyroo TN300Draeger Medical Systems, Inc.K213551Giraffe Omnibed Carestation CS1Datex Ohmeda, Inc.K201628Panda iRes Warmer, Giraffe WarmerGE HealthcareK200319HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface CableDeroyal Industries, Inc.K191425Hydro-Temp Neonatal Skin Temperature Probe CoverDeroyal Industries, Inc.

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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