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FDA 510(k)

V-2200 INFANT INCUBATOR

K-Number: K061856 · 2006-09-28

ApplicantAtom Medical, Inc.
Decision Date2006-09-28
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-2200 INFANT INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Atom Medical, Inc.. It received FDA 510(k) clearance on 2006-09-28 under 510(k) number K061856. 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 V-2200 INFANT INCUBATOR?

V-2200 INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 2006-09-28. The listed applicant is Atom Medical, Inc.. The 510(k) number is K061856.

When did V-2200 INFANT INCUBATOR receive FDA 510(k) clearance?

V-2200 INFANT INCUBATOR received FDA 510(k) clearance on 2006-09-28, under 510(k) number K061856.

Who is the listed applicant for V-2200 INFANT INCUBATOR?

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

What is the FDA product code for V-2200 INFANT INCUBATOR?

The FDA product code for V-2200 INFANT INCUBATOR is FMZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Atom 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.

K061071V-808 ATOM TRANSCAPSULEK060461V-505 INFA WARMER

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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