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FDA 510(k)

SOPRO 67D OPERATING ROOM CAMERA

K-Number: K013090 · 2001-12-13

ApplicantSopro
Decision Date2001-12-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SOPRO 67D OPERATING ROOM CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K013090. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOPRO 67D OPERATING ROOM CAMERA?

SOPRO 67D OPERATING ROOM CAMERA is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Sopro. The 510(k) number is K013090.

When did SOPRO 67D OPERATING ROOM CAMERA receive FDA 510(k) clearance?

SOPRO 67D OPERATING ROOM CAMERA received FDA 510(k) clearance on 2001-12-13, under 510(k) number K013090.

Who is the listed applicant for SOPRO 67D OPERATING ROOM CAMERA?

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 67D OPERATING ROOM CAMERA?

The FDA product code for SOPRO 67D OPERATING ROOM CAMERA is GCJ.

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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.

K223470C50K121685SOPROCAREK103813SOPRO 281K092329SOPIX 2K092583SOPROLIFEK082796SOPRO 184 CAMERA

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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