The following data is part of a premarket notification filed by Neumetry Medical Inc with the FDA for Somnometry.
| Device ID | K221179 |
| 510k Number | K221179 |
| Device Name: | SomnoMetry |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | Neumetry Medical Inc 47102 Mission Falls Ct. Suite 210 Fremont, CA 94539 |
| Contact | Paul Chen |
| Correspondent | Paul Chen Neumetry Medical Inc 47102 Mission Falls Ct. Suite 210 Fremont, CA 94539 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-09-21 |