510(k) K983198
K983198 is an FDA 510(k) premarket notification submitted by Diametrics Medical, Ltd. for the device "TRENDCARE CALIBRATOR MODEL SCU 7007". The FDA issued a decision of Substantially Equivalent on November 23, 1999. 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. Diametrics Medical, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1999
- Date Received
- September 11, 1998
- 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