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FDA 510(k)

S-357 VIDEO IMAGING SYSTEM

K-Number: K973798 · 1997-12-03

ApplicantSopro
Decision Date1997-12-03
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

S-357 VIDEO IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sopro. It received FDA 510(k) clearance on 1997-12-03 under 510(k) number K973798. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S-357 VIDEO IMAGING SYSTEM?

S-357 VIDEO IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-03. The listed applicant is Sopro. The 510(k) number is K973798.

When did S-357 VIDEO IMAGING SYSTEM receive FDA 510(k) clearance?

S-357 VIDEO IMAGING SYSTEM received FDA 510(k) clearance on 1997-12-03, under 510(k) number K973798.

Who is the listed applicant for S-357 VIDEO IMAGING SYSTEM?

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 S-357 VIDEO IMAGING SYSTEM?

The FDA product code for S-357 VIDEO IMAGING SYSTEM is FET.

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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: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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