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FDA 510(k)

S57D DIGITAL OPERATING ROOM CAMERA

K-Number: K000422 · 2000-03-31

ApplicantSopro
Decision Date2000-03-31
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

S57D DIGITAL 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 2000-03-31 under 510(k) number K000422. 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 S57D DIGITAL OPERATING ROOM CAMERA?

S57D DIGITAL OPERATING ROOM CAMERA is a medical device that received FDA 510(k) clearance on 2000-03-31. The listed applicant is Sopro. The 510(k) number is K000422.

When did S57D DIGITAL OPERATING ROOM CAMERA receive FDA 510(k) clearance?

S57D DIGITAL OPERATING ROOM CAMERA received FDA 510(k) clearance on 2000-03-31, under 510(k) number K000422.

Who is the listed applicant for S57D DIGITAL 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 S57D DIGITAL OPERATING ROOM CAMERA?

The FDA product code for S57D DIGITAL 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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