The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Visera Rhino-laryngovideoscope Olympus Enf Type V.
| Device ID | K031648 |
| 510k Number | K031648 |
| Device Name: | VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-07-24 |
| Summary: | summary |