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FDA 510(k)

VERSALET 7700 CARE CENTER, MODEL # 7700

K-Number: K993051 · 2000-02-03

ApplicantHill-Rom Air-Shields
Decision Date2000-02-03
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VERSALET 7700 CARE CENTER, MODEL # 7700 is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Air-Shields. It received FDA 510(k) clearance on 2000-02-03 under 510(k) number K993051. 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, MODEL # 7700?

VERSALET 7700 CARE CENTER, MODEL # 7700 is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is Hill-Rom Air-Shields. The 510(k) number is K993051.

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

VERSALET 7700 CARE CENTER, MODEL # 7700 received FDA 510(k) clearance on 2000-02-03, under 510(k) number K993051.

Who is the listed applicant for VERSALET 7700 CARE CENTER, MODEL # 7700?

The FDA 510(k) record lists Hill-Rom Air-Shields as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

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Other records listing Hill-Rom Air-Shields 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.

K021622HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103K003335RESUSCITAIRE RADIANT WARMER; RESUSCITAIRE BIRTHING ROOM WARMER; RESUSCITAIR WALL MOUNTED RADIANT WARMERK001242ISOLETTE INFANT INCUBATOR, MODEL C2HSK001019TI500 GLOBE-TROTTER TRANSPORT SYSTEM

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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