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FDA 510(k)

INCU I

K-Number: K102279 · 2010-12-29

ApplicantAtom Medical Corporation
Decision Date2010-12-29
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INCU I is the device name listed in this FDA 510(k) record. The listed applicant is Atom Medical Corporation. It received FDA 510(k) clearance on 2010-12-29 under 510(k) number K102279. 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 INCU I?

INCU I is a medical device that received FDA 510(k) clearance on 2010-12-29. The listed applicant is Atom Medical Corporation. The 510(k) number is K102279.

When did INCU I receive FDA 510(k) clearance?

INCU I received FDA 510(k) clearance on 2010-12-29, under 510(k) number K102279.

Who is the listed applicant for INCU I?

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

What is the FDA product code for INCU I?

The FDA product code for INCU I is FMZ.

Other records listing Atom Medical Corporation 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.

K123937ATOM TRANSCAPSULE V-707K120937SUNFLOWER WARNERK111547BILI-THERAPY PAD TYPEK103317RESUSCITATION UNIT 105K102542RESUSCI FLOW; RESUSCI FLOW 104K103828BILI-THERAPY SPOT TYPE

View all 10 devices →

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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