FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
NIBP 9225 COMBI
K Number: K912815
·
Decision Oct 9, 1992
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
46
Review Days
491
Basic Information
- Device Name
- NIBP 9225 COMBI
- K Number
- K912815
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S & W MEDICO TEKNIK
- Date Received
- June 6, 1991
- Decision Date
- October 9, 1992
- Product Code
- DXN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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