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FDA 510(k)

SOPRO 281

K-Number: K103813 · 2011-03-22

ApplicantSopro
Decision Date2011-03-22
Product CodeNTN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOPRO 281 is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2011-03-22 under 510(k) number K103813. The device is classified under product code NTN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPRO 281?

SOPRO 281 is a medical device that received FDA 510(k) clearance on 2011-03-22. The listed applicant is Sopro. The 510(k) number is K103813.

When did SOPRO 281 receive FDA 510(k) clearance?

SOPRO 281 received FDA 510(k) clearance on 2011-03-22, under 510(k) number K103813.

Who is the listed applicant for SOPRO 281?

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

What is the FDA product code for SOPRO 281?

The FDA product code for SOPRO 281 is NTN.

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Other records listing Sopro 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.

K223470C50K121685SOPROCAREK092329SOPIX 2K092583SOPROLIFEK082796SOPRO 184 CAMERAK080122SOPRO 670 ARTHROSCOPIC PUMP

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Related Devices (Code: NTN)

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.

K130819CLL- V1 LIGHT SOURCEOlympus Winter & Ibe GmbHK122831VIDEO SYSTEM CENTEROlympus Medical Systems Corp.K113679LUCEA LED SURGICAL LIGHT SYSTEMMaquet S.A.S.K102167LO-50 LED LIGHT SOURCEFiberoptics Technology, Inc.K091829PLS PORTABLE LIGHT SOURCEOptim, Inc.K090601FSC 2Schoelly Imaging, Inc.

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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