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FDA 510(k)

ATOM TRANSCAPSULE V-707

K-Number: K123937 · 2013-05-23

ApplicantAtom Medical Corporation
Decision Date2013-05-23
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ATOM TRANSCAPSULE V-707 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 2013-05-23 under 510(k) number K123937. The device is classified under product code FPL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATOM TRANSCAPSULE V-707?

ATOM TRANSCAPSULE V-707 is a medical device that received FDA 510(k) clearance on 2013-05-23. The listed applicant is Atom Medical Corporation. The 510(k) number is K123937.

When did ATOM TRANSCAPSULE V-707 receive FDA 510(k) clearance?

ATOM TRANSCAPSULE V-707 received FDA 510(k) clearance on 2013-05-23, under 510(k) number K123937.

Who is the listed applicant for ATOM TRANSCAPSULE V-707?

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 ATOM TRANSCAPSULE V-707?

The FDA product code for ATOM TRANSCAPSULE V-707 is FPL.

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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.

K120937SUNFLOWER WARNERK111547BILI-THERAPY PAD TYPEK103317RESUSCITATION UNIT 105K102542RESUSCI FLOW; RESUSCI FLOW 104K103828BILI-THERAPY SPOT TYPEK102227INFA WARMER I

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Related Devices (Code: FPL)

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K220742NxtGen Infant Transport IncubatorInternational BiomedicalK161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical SystemsK103525A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOXInternational Biomedical, Ltd.K103523185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.K103524VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.K103527AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, 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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