510(k) K181541
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK by
Andon Health Co, Ltd.
— Product Code MWI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2019
- Date Received
- June 11, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
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