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FDA 510(k)

PREEMICARE MODEL D1-X1, SERIES 3000

K-Number: K881476 · 1988-12-08

ApplicantPreemicare Corp.
Decision Date1988-12-08
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PREEMICARE MODEL D1-X1, SERIES 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Preemicare Corp.. It received FDA 510(k) clearance on 1988-12-08 under 510(k) number K881476. 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 PREEMICARE MODEL D1-X1, SERIES 3000?

PREEMICARE MODEL D1-X1, SERIES 3000 is a medical device that received FDA 510(k) clearance on 1988-12-08. The listed applicant is Preemicare Corp.. The 510(k) number is K881476.

When did PREEMICARE MODEL D1-X1, SERIES 3000 receive FDA 510(k) clearance?

PREEMICARE MODEL D1-X1, SERIES 3000 received FDA 510(k) clearance on 1988-12-08, under 510(k) number K881476.

Who is the listed applicant for PREEMICARE MODEL D1-X1, SERIES 3000?

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 MODEL D1-X1, SERIES 3000?

The FDA product code for PREEMICARE MODEL D1-X1, SERIES 3000 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 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: 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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