FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHEFFIELD INFANT VENTILATOR MARK 4
K Number: K812961
·
Decision Mar 26, 1982
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
498
Applicant Total
9
Review Days
156
Basic Information
- Device Name
- SHEFFIELD INFANT VENTILATOR MARK 4
- K Number
- K812961
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- CAIRCO LTD.
- Date Received
- October 21, 1981
- Decision Date
- March 26, 1982
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by CAIRCO LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K812957 | EAST AUTOCLAVE HUMIDIFIER | Mar 12, 1982 | Substantially Equivalent |
| K812956 | SPIROX H | Jan 22, 1982 | Substantially Equivalent |
| K812959 | SPIROX A | Jan 22, 1982 | Substantially Equivalent |
| K812958 | EAST-FREEMAN VENTILATOR MARK 2 | Jan 7, 1982 | Substantially Equivalent |
| K812955 | EAST WATER UNIT MARK 3 | Dec 29, 1981 | Substantially Equivalent |
| K812953 | RADCLIFFE VENTILATOR MARK 5 | Nov 27, 1981 | Substantially Equivalent |
| K812960 | EAST VENTILARM PRESSURE MONITOR ALARM S. | Nov 16, 1981 | Substantially Equivalent |
| K810640 | POLARISED LIGHT GRONIOMETER | Apr 17, 1981 | Substantially Equivalent |