THERMODILUTION CATHETER
FDA 510(k) clearance K083384 · decided 2010-01-05
Clearance details
- K-number
- K083384
- Device name
- THERMODILUTION CATHETER
- Applicant
- Biosensors Intl. Pte. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-17
- Decision date
- 2010-01-05
- Days to decision
- 414 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Singapore, SG
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.