510(k) K153557
K153557 is an FDA 510(k) premarket notification submitted by I.E.M. GmbH for the device "ABPM 7100, Hypertension Management Software". The FDA issued a decision of Substantially Equivalent on Jul 19, 2016. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. I.E.M. GmbH has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 19, 2016
- Date Received
- Dec 14, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)