The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Remote Patient Monitoring (rpm).
Device ID | K110503 |
510k Number | K110503 |
Device Name: | AIRSTRIP REMOTE PATIENT MONITORING (RPM) |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | AIRSTRIP TECHNOLOGIES, LP 3303 OAKWELL CT., SUITE 200 San Antonio, TX 78218 |
Contact | Andy Miller |
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 | 2011-02-22 |
Decision Date | 2011-03-10 |