The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Neuroscope, Models S-1349/1, S-1349/2, S-1349/3 And S-1349/4.
| Device ID | K020507 |
| 510k Number | K020507 |
| Device Name: | OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 |
| Classification | Endoscope, Neurological |
| Applicant | OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-15 |
| Decision Date | 2002-10-08 |
| Summary: | summary |