510(k) K905775
K905775 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS ETCO2 CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 11, 1991. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1991
- Date Received
- December 27, 1990
- 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