510(k) K970801
K970801 is an FDA 510(k) premarket notification submitted by Bci Intl., Inc. for the device "BCI MODEL 6004 NIBP MONITOR (6004)". The FDA issued a decision of Substantially Equivalent on November 12, 1997. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Bci Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1997
- Date Received
- March 4, 1997
- 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