The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Da Vinchi Eeg And Emg/ep Systems.
| Device ID | K000963 |
| 510k Number | K000963 |
| Device Name: | DA VINCHI EEG AND EMG/EP SYSTEMS |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Contact | Peter Weisenborn |
| Correspondent | Peter Weisenborn AIRSEP CORP. 290 CREEKSIDE DR. Buffalo, NY 14228 |
| Product Code | GWF |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | GWQ |
| Subsequent Product Code | IKN |
| Subsequent Product Code | JXE |
| Subsequent Product Code | OLT |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-10-20 |