CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
FDA 510(k) clearance K022004 · decided 2003-03-12
Clearance details
- K-number
- K022004
- Device name
- CARDIAC OUTPUT KIT, MODEL CO-1 & INLINE SENSOR CABLE, MODEL ILS-1
- Applicant
- Biosensors International-USA
- Decision
- Substantially Equivalent
- Date received
- 2002-06-19
- Decision date
- 2003-03-12
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Newport Beach, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.