The following data is part of a premarket notification filed by Sibel Inc. with the FDA for Anne Sleep.
| Device ID | K220095 |
| 510k Number | K220095 |
| Device Name: | ANNE Sleep |
| Classification | Ventilatory Effort Recorder |
| Applicant | Sibel Inc. 6650 W. Touhy Ave. Niles, IL 60714 |
| Contact | Peter Xu |
| Correspondent | Sarah Coughlin Sibel Inc. 6650 W. Touhy Ave. Niles, IL 60714 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004541714 | K220095 | 000 |