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FDA 510(k)

V-808 ATOM TRANSCAPSULE

K-Number: K061071 · 2006-08-29

ApplicantAtom Medical, Inc.
Decision Date2006-08-29
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

V-808 ATOM TRANSCAPSULE 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 2006-08-29 under 510(k) number K061071. 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 V-808 ATOM TRANSCAPSULE?

V-808 ATOM TRANSCAPSULE is a medical device that received FDA 510(k) clearance on 2006-08-29. The listed applicant is Atom Medical, Inc.. The 510(k) number is K061071.

When did V-808 ATOM TRANSCAPSULE receive FDA 510(k) clearance?

V-808 ATOM TRANSCAPSULE received FDA 510(k) clearance on 2006-08-29, under 510(k) number K061071.

Who is the listed applicant for V-808 ATOM TRANSCAPSULE?

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-808 ATOM TRANSCAPSULE?

The FDA product code for V-808 ATOM TRANSCAPSULE is FPL.

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, 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.

K061856V-2200 INFANT INCUBATORK060461V-505 INFA WARMER

Related Devices (Code: FPL)

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.

K220742NxtGen Infant Transport IncubatorInternational BiomedicalK161918SREE MRI Transport IncubatorAdvanced Imaging Research Dba Sree Medical SystemsK123937ATOM TRANSCAPSULE V-707Atom Medical CorporationK103523185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOXInternational Biomedical, Ltd.K103525A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOXInternational Biomedical, Ltd.K103524VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER 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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