The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Hd Camera Head Otv-s7proh-hd-l08e.
Device ID | K083155 |
510k Number | K083155 |
Device Name: | HD CAMERA HEAD OTV-S7PROH-HD-L08E |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
Contact | Stacy A Kluesner |
Correspondent | Stacy A Kluesner OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley, PA 18034 -0610 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-10-24 |
Decision Date | 2009-01-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170268267 | K083155 | 000 |