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FDA 510(k)

VERSALET 7700 CARE CENTER

K-Number: K053399 · 2006-08-04

ApplicantDraeger Medical Infant Care, Inc.
Decision Date2006-08-04
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERSALET 7700 CARE CENTER is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Infant Care, Inc.. It received FDA 510(k) clearance on 2006-08-04 under 510(k) number K053399. 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 VERSALET 7700 CARE CENTER?

VERSALET 7700 CARE CENTER is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Draeger Medical Infant Care, Inc.. The 510(k) number is K053399.

When did VERSALET 7700 CARE CENTER receive FDA 510(k) clearance?

VERSALET 7700 CARE CENTER received FDA 510(k) clearance on 2006-08-04, under 510(k) number K053399.

Who is the listed applicant for VERSALET 7700 CARE CENTER?

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

What is the FDA product code for VERSALET 7700 CARE CENTER?

The FDA product code for VERSALET 7700 CARE CENTER is FMZ.

Related Clinical Trials

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Other records listing Draeger Medical Infant Care, 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.

K042522JAUNDICE METER, MODEL JM 103

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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