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FDA 510(k)

BABYTHERM 8000 LDR

K-Number: K980886 · 1998-05-29

ApplicantDraeger Medical, Inc.
Decision Date1998-05-29
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BABYTHERM 8000 LDR is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 1998-05-29 under 510(k) number K980886. 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 BABYTHERM 8000 LDR?

BABYTHERM 8000 LDR is a medical device that received FDA 510(k) clearance on 1998-05-29. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K980886.

When did BABYTHERM 8000 LDR receive FDA 510(k) clearance?

BABYTHERM 8000 LDR received FDA 510(k) clearance on 1998-05-29, under 510(k) number K980886.

Who is the listed applicant for BABYTHERM 8000 LDR?

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

What is the FDA product code for BABYTHERM 8000 LDR?

The FDA product code for BABYTHERM 8000 LDR is FMZ.

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Other records listing Draeger Medical, Inc. 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.

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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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