FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINICO
K Number: K781746
·
Decision Dec 5, 1978
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
27
Applicant Total
9
Review Days
48
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Basic Information
- Device Name
- MINICO
- K Number
- K781746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1430
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Catalyst Research Corp.
- Date Received
- October 18, 1978
- Decision Date
- December 5, 1978
- Product Code
- CCJ
- 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 |
|---|---|---|---|
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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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 |
| K833326 | MINI OX III OXYGEN MONITOR | Nov 3, 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 |