The following data is part of a premarket notification filed by Neuro Navigational Corp. with the FDA for 2.3 Mm Disposable Neuroview Endoscope.
| Device ID | K940483 |
| 510k Number | K940483 |
| Device Name: | 2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE |
| Classification | Arthroscope |
| Applicant | NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Contact | Karen U Salinas |
| Correspondent | Karen U Salinas NEURO NAVIGATIONAL CORP. 3180 PULLMAN ST. Costa Mesa, CA 92626 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1995-05-02 |