The following data is part of a premarket notification filed by Airsep Corp. with the FDA for Monet Acquisition System For Eeg And Polysomnography.
| Device ID | K001013 |
| 510k Number | K001013 |
| Device Name: | MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY |
| Classification | Standard Polysomnograph With Electroencephalograph |
| 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 | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-29 |
| Decision Date | 2000-05-16 |