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FDA 510(k)

SOPROCARE

K-Number: K121685 · 2013-03-12

ApplicantSopro
Decision Date2013-03-12
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOPROCARE is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2013-03-12 under 510(k) number K121685. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPROCARE?

SOPROCARE is a medical device that received FDA 510(k) clearance on 2013-03-12. The listed applicant is Sopro. The 510(k) number is K121685.

When did SOPROCARE receive FDA 510(k) clearance?

SOPROCARE received FDA 510(k) clearance on 2013-03-12, under 510(k) number K121685.

Who is the listed applicant for SOPROCARE?

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 SOPROCARE?

The FDA product code for SOPROCARE is NBL.

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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.

K223470C50K103813SOPRO 281K092329SOPIX 2K092583SOPROLIFEK082796SOPRO 184 CAMERAK080122SOPRO 670 ARTHROSCOPIC PUMP

View all 25 devices →

Related Devices (Code: NBL)

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.

K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.K242103TRIOS Ready Tip3Shape TRIOS A/SK221275Qraycam PROAIOBIO Co., Ltd.K231722SmarToothSmartooth Co., Ltd.K223470C50SoproK221249L1P-1F (TRIOS 5)3Shape TRIOS A/S

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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