510(k) K940188
K940188 is an FDA 510(k) premarket notification submitted by Biomedical Sensors, Ltd. for the device "PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 1995. The device falls under product code CCC (Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1150. Biomedical Sensors, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1995
- Date Received
- January 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1150
- Review Panel
- AN
- Submission Type