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FDA 510(k)

ISOLETTE INFANT INCUBATOR, MODEL C2000E

K-Number: K031387 · 2003-08-01

ApplicantHill-Rom Manufacturing, Inc.
Decision Date2003-08-01
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLETTE INFANT INCUBATOR, MODEL C2000E is the device name listed in this FDA 510(k) record. The listed applicant is Hill-Rom Manufacturing, Inc.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K031387. 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 ISOLETTE INFANT INCUBATOR, MODEL C2000E?

ISOLETTE INFANT INCUBATOR, MODEL C2000E is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Hill-Rom Manufacturing, Inc.. The 510(k) number is K031387.

When did ISOLETTE INFANT INCUBATOR, MODEL C2000E receive FDA 510(k) clearance?

ISOLETTE INFANT INCUBATOR, MODEL C2000E received FDA 510(k) clearance on 2003-08-01, under 510(k) number K031387.

Who is the listed applicant for ISOLETTE INFANT INCUBATOR, MODEL C2000E?

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

What is the FDA product code for ISOLETTE INFANT INCUBATOR, MODEL C2000E?

The FDA product code for ISOLETTE INFANT INCUBATOR, MODEL C2000E is FMZ.

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Other records listing Hill-Rom Manufacturing, Inc. as applicant

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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

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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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