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FDA 510(k)

NEO-SERVO I

K-Number: K102710 · 2010-12-22

ApplicantAtom Medical Corporation
Decision Date2010-12-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NEO-SERVO 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 2010-12-22 under 510(k) number K102710. 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 NEO-SERVO I?

NEO-SERVO I is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Atom Medical Corporation. The 510(k) number is K102710.

When did NEO-SERVO I receive FDA 510(k) clearance?

NEO-SERVO I received FDA 510(k) clearance on 2010-12-22, under 510(k) number K102710.

Who is the listed applicant for NEO-SERVO 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 NEO-SERVO I?

The FDA product code for NEO-SERVO I is FMZ.

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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

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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

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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