510(k) K875268
K875268 is an FDA 510(k) premarket notification submitted by Traverse Medical Monitors for the device "TMM MODEL 2500 CAPMONITOR". The FDA issued a decision of Substantially Equivalent on January 22, 1988. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Traverse Medical Monitors has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1988
- Date Received
- December 22, 1987
- 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