The following data is part of a premarket notification filed by Alertwatch, Inc. with the FDA for Alertwatch:ac.
| Device ID | K210160 |
| 510k Number | K210160 |
| Device Name: | AlertWatch:AC |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | AlertWatch, Inc. 330 East Liberty St., Fourth Floor Ann Arbor, MI 48104 |
| Contact | Justin Adams |
| Correspondent | Donna-bea Tillman Biologics Consulting Group, Inc. 1555 King Street, Suite 300 Alexandria, VA 22314 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-09-10 |