NIBP 9225 COMBI
FDA 510(k) clearance K912815 · decided 1992-10-09
Clearance details
- K-number
- K912815
- Device name
- NIBP 9225 COMBI
- Applicant
- S & W Medico Teknik
- Decision
- Substantially Equivalent
- Date received
- 1991-06-06
- Decision date
- 1992-10-09
- Days to decision
- 491 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Denmark, DK
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.