510(k) K012013
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2001
- Date Received
- June 28, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type