The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for V1 System.
| Device ID | K111756 |
| 510k Number | K111756 |
| Device Name: | V1 SYSTEM |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy Abbatiello Kluesner |
| Correspondent | Stacy Abbatiello Kluesner OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-22 |
| Decision Date | 2012-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170356384 | K111756 | 000 |
| 04953170312410 | K111756 | 000 |
| 04953170312397 | K111756 | 000 |
| 04953170312373 | K111756 | 000 |
| 04953170312359 | K111756 | 000 |