FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REGULATOR, OXYGEN MECHANICAL
K Number: K803207
·
Decision Jan 15, 1981
Classifications
1
FEI Numbers
111
Registration Numbers
112
Same Product Code
54
Applicant Total
29
Review Days
28
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Basic Information
- Device Name
- REGULATOR, OXYGEN MECHANICAL
- K Number
- K803207
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2700
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Timeter Instrument Corp.
- Date Received
- December 18, 1980
- Decision Date
- January 15, 1981
- Product Code
- CAN
- 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 |
|---|---|---|---|
| CAN | Regulator, Pressure, Gas Cylinder | FDA class 1 | Anesthesiology |
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Other Clearances by Timeter Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| K871603 | CRITERION II & IIA OXYGEN CONCENTRATORS | Aug 13, 1987 | Substantially Equivalent |
| K864836 | L.A.P. SPIROMETER | Mar 6, 1987 | Substantially Equivalent |
| K834274 | CRITERION I | Apr 13, 1984 | Substantially Equivalent |
| K823775 | BORDON GAGE REGULATOR #BG | Jan 14, 1983 | Substantially Equivalent |
| K822746 | RT-200 CALIBRATION ANALYZER | Oct 13, 1982 | Substantially Equivalent |
| K812766 | PCS-5 ACCESSORIES | Dec 17, 1981 | Substantially Equivalent |
| K813235 | DISS FEMALE AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |
| K813234 | OHIO AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |