The following data is part of a premarket notification filed by Ensodata, Inc. with the FDA for Ensosleep.
| Device ID | K162627 |
| 510k Number | K162627 |
| Device Name: | EnsoSleep |
| Classification | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Applicant | EnsoData, Inc. 111 N. Fairchild Street, Suite 240 Madison, WI 53703 |
| Contact | Chris Fernandez |
| Correspondent | Seth A. Mailhot Michael Best & Friedrich, LLP 601 Pennsylvania Ave, NW Suite 700 South Washington, DC 20004 |
| Product Code | OLZ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864458000407 | K162627 | 000 |