The following data is part of a premarket notification filed by Olympus Optical, Co. with the FDA for Olympus Neuro Endoscope.
| Device ID | K971340 |
| 510k Number | K971340 |
| Device Name: | OLYMPUS NEURO ENDOSCOPE |
| Classification | Endoscope, Neurological |
| Applicant | OLYMPUS OPTICAL, CO. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk OLYMPUS OPTICAL, CO. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1998-07-29 |
| Summary: | summary |