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FDA 510(k)

INFA WARMER I

K-Number: K102227 · 2011-01-21

ApplicantAtom Medical Corporation
Decision Date2011-01-21
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFA WARMER 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 2011-01-21 under 510(k) number K102227. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFA WARMER I?

INFA WARMER I is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Atom Medical Corporation. The 510(k) number is K102227.

When did INFA WARMER I receive FDA 510(k) clearance?

INFA WARMER I received FDA 510(k) clearance on 2011-01-21, under 510(k) number K102227.

Who is the listed applicant for INFA WARMER 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 INFA WARMER I?

The FDA product code for INFA WARMER I is FMT.

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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: FMT)

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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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