The following data is part of a premarket notification filed by Alertwatch, Inc. with the FDA for Alertwatch:ob.
| Device ID | K173715 |
| 510k Number | K173715 |
| Device Name: | AlertWatch:OB |
| Classification | System, Monitoring, Perinatal |
| Applicant | AlertWatch, Inc. 1600 Huron Parkway, Bldg. 520, Ste. 2326 Ann Arbor, MI 48109 |
| Contact | Justin Adams |
| Correspondent | Donna-bea Tillman Biologics Consulting Group, Inc. 1555 King Street Suite 300 Alexandria, VA 22314 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-04 |
| Decision Date | 2018-04-23 |
| Summary: | summary |