QUANTIEN MEASUREMENT SYSTEM
FDA 510(k) clearance K123984 · decided 2013-03-28
Clearance details
- K-number
- K123984
- Device name
- QUANTIEN MEASUREMENT SYSTEM
- Applicant
- Radi Medical Systems AB
- Decision
- Substantially Equivalent
- Date received
- 2012-12-26
- Decision date
- 2013-03-28
- Days to decision
- 92 days
- Clearance type
- Special
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.