510(k) K100133
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 by
Airstrip Technologies, LP
— Product Code MWI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2010
- Date Received
- January 19, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type