510(k) K790785
K790785 is an FDA 510(k) premarket notification submitted by Catalyst Research Corp. for the device "MODEL M25RL, (CRC) OXYGEN ANALYZER". The FDA issued a decision of Substantially Equivalent on Apr 27, 1979. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Catalyst Research Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 27, 1979
- Date Received
- Apr 23, 1979
- 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