510(k) K003732
K003732 is an FDA 510(k) premarket notification submitted by Braun GmbH for the device "BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES". The FDA issued a decision of Substantially Equivalent on May 16, 2001. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Braun GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 2001
- Date Received
- December 4, 2000
- 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