FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINI OX III OXYGEN MONITOR
K Number: K833326
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
9
Review Days
37
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Basic Information
- Device Name
- MINI OX III OXYGEN MONITOR
- K Number
- K833326
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.1030
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Catalyst Research Corp.
- Date Received
- September 27, 1983
- Decision Date
- November 3, 1983
- Product Code
- BXL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BXL | Algesimeter, Manual | FDA class 1 | Anesthesiology |
Other Clearances by Catalyst Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K905310 | MINIOX V PULSE OXIMETER | May 28, 1991 | Substantially Equivalent |
| K874132 | MINIOX IV PORTABLE PULSE OXIMETER | Jan 19, 1988 | Substantially Equivalent |
| K862798 | MINIOX 100 PULSE OXIMETER | Aug 28, 1986 | Substantially Equivalent |
| K833995 | MINI OX II | Dec 12, 1983 | Substantially Equivalent |
| K790785 | MODEL M25RL, (CRC) OXYGEN ANALYZER | Apr 27, 1979 | Substantially Equivalent |
| K790784 | MODEL M25R, OXYGEN ANALYZER | Apr 27, 1979 | Substantially Equivalent |
| K782062 | ANALYZER, OXYGEN MODEL M25RA & M25RAD | Feb 15, 1979 | Substantially Equivalent |
| K781746 | MINICO | Dec 5, 1978 | Substantially Equivalent |