510(k) K024155
K024155 is an FDA 510(k) premarket notification submitted by Teledyne Analytical Instruments for the device "MX 300 OXYGEN MONITOR". The FDA issued a decision of Substantially Equivalent on July 17, 2003. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Teledyne Analytical Instruments has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2003
- Date Received
- December 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Gas, Oxygen, Gaseous-Phase
- Device Class
- Class II
- Regulation Number
- 868.1720
- Review Panel
- AN
- Submission Type