FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
MODIFICATION TO THE OXYCONALPHA
K Number: K980094
·
Decision Jul 28, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
3
Review Days
200
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Basic Information
- Device Name
- MODIFICATION TO THE OXYCONALPHA
- K Number
- K980094
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erich Jaeger B.V.
- Date Received
- January 9, 1998
- Decision Date
- July 28, 1998
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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