The following data is part of a premarket notification filed by Alertwatch Llc with the FDA for Alertwatch: Or.
| Device ID | K153335 |
| 510k Number | K153335 |
| Device Name: | AlertWatch: OR |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | ALERTWATCH LLC 1600 HURON PARKWAY, BLDG. 520, STE. 2326 Ann Arbor, MI 48109 |
| Contact | Justin Adams |
| Correspondent | Donna-bea Tillman BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON STREET SUITE 100 Alexandria, VA 22314 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-03-15 |
| Summary: | summary |