510(k) K070128
K070128 is an FDA 510(k) premarket notification submitted by Westmed, Inc. for the device "CO2 EASY". The FDA issued a decision of Substantially Equivalent on February 15, 2007. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Westmed, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2007
- Date Received
- January 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1400
- Review Panel
- AN
- Submission Type