The following data is part of a premarket notification filed by Sibel Inc. with the FDA for Anne One.
| Device ID | K211305 |
| 510k Number | K211305 |
| Device Name: | ANNE One |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | Sibel Inc. 6650 W Touhy Ave Niles, IL 60714 |
| Contact | Peter Xu |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | DRG |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-04-29 |
| Decision Date | 2021-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004541707 | K211305 | 000 |