FINOMETER MODEL-2 WITH ACCESSORIES
FDA 510(k) clearance K063111 · decided 2007-02-01
Clearance details
- K-number
- K063111
- Device name
- FINOMETER MODEL-2 WITH ACCESSORIES
- Applicant
- Finapres Medical Systems B.V.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-11
- Decision date
- 2007-02-01
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Amsterdam Zo, NL
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.