510(k) K110603
K110603 is an FDA 510(k) premarket notification submitted by I.E.M. GmbH for the device "HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)". The FDA issued a decision of Substantially Equivalent on Dec 16, 2011. 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
- Dec 16, 2011
- Date Received
- Mar 3, 2011
- 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)