The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Da Vinchi Emg/ep Isa1004ep.
| Device ID | K001467 |
| 510k Number | K001467 |
| Device Name: | DA VINCHI EMG/EP ISA1004EP |
| Classification | Stimulator, Photic, 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 | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| CFR Regulation Number | 882.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-10 |
| Decision Date | 2000-08-01 |