The following data is part of a premarket notification filed by Medapps Inc., Dba Alere Connect with the FDA for Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile Link.
| Device ID | K132803 |
| 510k Number | K132803 |
| Device Name: | MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM, HEALTHPAL, HEALTHCOM, MOBILE LINK |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | MEDAPPS INC., DBA ALERE CONNECT 8767 E. VIA DE VENTURA, STE 300 Scottsdale, AZ 85258 |
| Contact | Kent Dicks |
| Correspondent | Kent Dicks MEDAPPS INC., DBA ALERE CONNECT 8767 E. VIA DE VENTURA, STE 300 Scottsdale, AZ 85258 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-06 |
| Decision Date | 2013-12-12 |
| Summary: | summary |