510(k) K925484
K925484 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer for the device "CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308". The FDA issued a decision of Substantially Equivalent on June 22, 1993. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Bruel & Kjaer has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1993
- Date Received
- October 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type