The following data is part of a premarket notification filed by Ensodata, Inc. with the FDA for Ensosleep.
| Device ID | K210034 |
| 510k Number | K210034 |
| Device Name: | EnsoSleep |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | EnsoData, Inc. 111 S. Hamilton St. Suite 30 Madison, WI 53703 |
| Contact | Sigrid Schoepel |
| Correspondent | Sigrid Schoepel EnsoData, Inc. 111 S. Hamilton St. Suite 30 Madison, WI 53703 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-06 |
| Decision Date | 2021-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864458000414 | K210034 | 000 |