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FDA 510(k)

V-2100G ADVANCED INFANT INCUBATOR

K-Number: K021809 · 2002-07-18

ApplicantAtom Medical Corp
Decision Date2002-07-18
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-2100G ADVANCED INFANT INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Atom Medical Corp. It received FDA 510(k) clearance on 2002-07-18 under 510(k) number K021809. 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-2100G ADVANCED INFANT INCUBATOR?

V-2100G ADVANCED INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 2002-07-18. The listed applicant is Atom Medical Corp. The 510(k) number is K021809.

When did V-2100G ADVANCED INFANT INCUBATOR receive FDA 510(k) clearance?

V-2100G ADVANCED INFANT INCUBATOR received FDA 510(k) clearance on 2002-07-18, under 510(k) number K021809.

Who is the listed applicant for V-2100G ADVANCED INFANT INCUBATOR?

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

What is the FDA product code for V-2100G ADVANCED INFANT INCUBATOR?

The FDA product code for V-2100G ADVANCED 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.

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Other records listing Atom Medical Corp 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.

K002355ATOM INFA WARMER V-505

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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