The following data is part of a premarket notification filed by Machida Endoscope Co., Ltd. with the FDA for Machida Flexible Neuro-endoscope, Models Neu-4, Neu-4l.
| Device ID | K993568 |
| 510k Number | K993568 |
| Device Name: | MACHIDA FLEXIBLE NEURO-ENDOSCOPE, MODELS NEU-4, NEU-4L |
| Classification | Endoscope, Neurological |
| Applicant | MACHIDA ENDOSCOPE CO., LTD. 13-8, HONKOMAGOME 6-CHOME, BUNKYO-KU Tokyo, JP |
| Contact | Genichi Kanai |
| Correspondent | Genichi Kanai MACHIDA ENDOSCOPE CO., LTD. 13-8, HONKOMAGOME 6-CHOME, BUNKYO-KU Tokyo, JP |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-21 |
| Decision Date | 2000-03-13 |
| Summary: | summary |