MINI OX III OXYGEN MONITOR
FDA 510(k) clearance K833326 · decided 1983-11-03
Clearance details
- K-number
- K833326
- Device name
- MINI OX III OXYGEN MONITOR
- Applicant
- Catalyst Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-27
- Decision date
- 1983-11-03
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- BXL
- Device class
- 1
- Regulation number
- 868.1030
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.