The following data is part of a premarket notification filed by Alertwatch Llc with the FDA for Alertwatch: Or.
| Device ID | K130401 |
| 510k Number | K130401 |
| Device Name: | ALERTWATCH: OR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | ALERTWATCH LLC 6594 AUTUMN WIND CIRCLE Clarksville, MD 21029 |
| Contact | Donna-bea Tillman |
| Correspondent | Donna-bea Tillman ALERTWATCH LLC 6594 AUTUMN WIND CIRCLE Clarksville, MD 21029 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2014-02-07 |
| Summary: | summary |