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FDA 510(k)

SI ASCOPE

K-Number: K011273 · 2002-02-20

ApplicantAstron Clinica Limited
Decision Date2002-02-20
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SI ASCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Astron Clinica Limited. It received FDA 510(k) clearance on 2002-02-20 under 510(k) number K011273. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SI ASCOPE?

SI ASCOPE is a medical device that received FDA 510(k) clearance on 2002-02-20. The listed applicant is Astron Clinica Limited. The 510(k) number is K011273.

When did SI ASCOPE receive FDA 510(k) clearance?

SI ASCOPE received FDA 510(k) clearance on 2002-02-20, under 510(k) number K011273.

Who is the listed applicant for SI ASCOPE?

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

What is the FDA product code for SI ASCOPE?

The FDA product code for SI ASCOPE is PSN.

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 Astron Clinica Limited 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.

K062736SIASCOPE VK023729SIASCOPE II

Related Devices (Code: PSN)

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.

K230448DeepX DermoSight DermatoscopeDeepx Health, LLCK213957Demetra Dermatoscope BDEM-01Barco N.V.K201408Demetra Analytics ToolkitBarco N.V.K192829Demetra BDEM-01 DermatoscopeBarco N.V.K180162VivaScope SystemCaliber Imaging & Diagnostics, Inc.K080788VIVASCOPE SYSTEM, MODEL 1500, 3000Lucid, Inc.

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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