510(k) K140928
K140928 is an FDA 510(k) premarket notification submitted by I.E.M. GmbH for the device "ABPM7100". The FDA issued a decision of Substantially Equivalent on Sep 15, 2014. 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
- Sep 15, 2014
- Date Received
- Apr 11, 2014
- 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)