510(k) K912030
K912030 is an FDA 510(k) premarket notification submitted by 3M Company for the device "CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED". The FDA issued a decision of Substantially Equivalent on October 30, 1991. The device falls under product code CBZ (Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling), a Class II device regulated under 21 CFR 868.1170. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1991
- Date Received
- May 7, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- Device Class
- Class II
- Regulation Number
- 868.1170
- Review Panel
- AN
- Submission Type