510(k) K072446
K072446 is an FDA 510(k) premarket notification submitted by I.E.M. GmbH for the device "MOBIL-O-GRAPH NG 24 H ABP-CONTROL". The FDA issued a decision of Substantially Equivalent on Nov 29, 2007. 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
- Nov 29, 2007
- Date Received
- Aug 30, 2007
- Clearance Type
- Special
- 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)