510(k) K071960
K071960 is an FDA 510(k) premarket notification submitted by Meditech Kft. for the device "MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05". The FDA issued a decision of Substantially Equivalent on Aug 3, 2007. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Meditech Kft. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 2007
- Date Received
- Jul 16, 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)