510(k) K930957
K930957 is an FDA 510(k) premarket notification submitted by Zefon Medical Products for the device "ZEFON GAS SAMPLING LINES". The FDA issued a decision of Substantially Equivalent (kit) on July 2, 1993. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Zefon Medical Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- July 2, 1993
- Date Received
- February 23, 1993
- 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