FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISS FEMALE AIR ADAPTOR
K Number: K813235
·
Decision Dec 8, 1981
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
29
Review Days
21
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Basic Information
- Device Name
- DISS FEMALE AIR ADAPTOR
- K Number
- K813235
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5710
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Timeter Instrument Corp.
- Date Received
- November 17, 1981
- Decision Date
- December 8, 1981
- Product Code
- BYK
- 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 |
|---|---|---|---|
| BYK | Tent, Oxygen, Electrically Powered | FDA class 2 | Anesthesiology |
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Other Clearances by Timeter Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K875075 | RT-200 COMPUTER INTERFACE | Apr 21, 1988 | Substantially Equivalent |
| K875074 | VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 | Feb 22, 1988 | Substantially Equivalent |
| 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 |
| K813234 | OHIO AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |
| K812767 | SNIFF AIR COMPRESSOR #SF-6 | Nov 27, 1981 | Substantially Equivalent |