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 |