The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Remote Patient Monitoring (rpm) Remote Data Viewing.
| Device ID | K122133 |
| 510k Number | K122133 |
| Device Name: | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | AIRSTRIP TECHNOLOGIES, LP 335 E. SONTERRA BLVD. SUITE 200 San Antonio, TX 78258 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-07-18 |
| Decision Date | 2012-10-02 |
| Summary: | summary |