510(k) K833326
K833326 is an FDA 510(k) premarket notification submitted by Catalyst Research Corp. for the device "MINI OX III OXYGEN MONITOR". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code BXL (Algesimeter, Manual), a Class I device regulated under 21 CFR 868.1030. Catalyst Research Corp. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1983
- Date Received
- September 27, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Algesimeter, Manual
- Device Class
- Class I
- Regulation Number
- 868.1030
- Review Panel
- AN
- Submission Type