The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Remote Patient Monitoring.
Device ID | K133394 |
510k Number | K133394 |
Device Name: | AIRSTRIP REMOTE PATIENT MONITORING |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | AIRSTRIP TECHNOLOGIES, LP 335 E. SONTERRA BLVD. SUITE 200 San Antonio, TX 78258 |
Contact | Robert A Miller |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-11-05 |
Decision Date | 2014-02-06 |