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FDA 510(k)

SEAL ONE

K-Number: K123035 · 2012-11-28

ApplicantPerouse Medical
Decision Date2012-11-28
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SEAL ONE is the device name listed in this FDA 510(k) record. The listed applicant is Perouse Medical. It received FDA 510(k) clearance on 2012-11-28 under 510(k) number K123035. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEAL ONE?

SEAL ONE is a medical device that received FDA 510(k) clearance on 2012-11-28. The listed applicant is Perouse Medical. The 510(k) number is K123035.

When did SEAL ONE receive FDA 510(k) clearance?

SEAL ONE received FDA 510(k) clearance on 2012-11-28, under 510(k) number K123035.

Who is the listed applicant for SEAL ONE?

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

What is the FDA product code for SEAL ONE?

The FDA product code for SEAL ONE is DXC.

Other records listing Perouse Medical 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.

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Related Devices (Code: DXC)

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.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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