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FDA 510(k)

HD CAMERA HEAD OTV-S7PROH-HD-L08E

K-Number: K083155 · 2009-01-13

ApplicantOlympus Medical Systems Corporation
Decision Date2009-01-13
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HD CAMERA HEAD OTV-S7PROH-HD-L08E is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2009-01-13 under 510(k) number K083155. 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 HD CAMERA HEAD OTV-S7PROH-HD-L08E?

HD CAMERA HEAD OTV-S7PROH-HD-L08E is a medical device that received FDA 510(k) clearance on 2009-01-13. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K083155.

When did HD CAMERA HEAD OTV-S7PROH-HD-L08E receive FDA 510(k) clearance?

HD CAMERA HEAD OTV-S7PROH-HD-L08E received FDA 510(k) clearance on 2009-01-13, under 510(k) number K083155.

Who is the listed applicant for HD CAMERA HEAD OTV-S7PROH-HD-L08E?

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

What is the FDA product code for HD CAMERA HEAD OTV-S7PROH-HD-L08E?

The FDA product code for HD CAMERA HEAD OTV-S7PROH-HD-L08E is FET.

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Other records listing Olympus Medical Systems Corporation 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.

K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K260856Disposable Distal Attachment D-201-13404K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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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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