FDA 510(k)
Substantially Equivalent
🇳🇱 Netherlands
OXYCONALPHA WITH OPTION ECG
K Number: K984465
·
Decision Oct 27, 1999
Classifications
0
FEI Numbers
11
Registration Numbers
11
Same Product Code
82
Applicant Total
3
Review Days
315
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Basic Information
- Device Name
- OXYCONALPHA WITH OPTION ECG
- K Number
- K984465
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Erich Jaeger B.V.
- Date Received
- December 16, 1998
- Decision Date
- October 27, 1999
- Product Code
- LOS
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
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