FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENTRONICS #5590 ECII OXYGEN MONITOR
K Number: K812854
·
Decision Nov 6, 1981
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
120
Applicant Total
2
Review Days
24
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Basic Information
- Device Name
- VENTRONICS #5590 ECII OXYGEN MONITOR
- K Number
- K812854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Ventronics, Div of Hudson Oxygen Therapy Sales Co.
- Date Received
- October 13, 1981
- Decision Date
- November 6, 1981
- Product Code
- CCL
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Ventronics, Div of Hudson Oxygen Therapy Sales Co.
| K Number | Device Name | ||
|---|---|---|---|
| K812855 | VENTRONICS #5595 ECII OXYGEN ANALYZER | Nov 6, 1981 | Substantially Equivalent |