510(k) K912815
K912815 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "NIBP 9225 COMBI". The FDA issued a decision of Substantially Equivalent on October 9, 1992. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. S & W Medico Teknik has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1992
- Date Received
- June 6, 1991
- 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