THERMODILUTION CATHETER
FDA 510(k) clearance K840992 · decided 1984-05-23
Clearance details
- K-number
- K840992
- Device name
- THERMODILUTION CATHETER
- Applicant
- Gould, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-07
- Decision date
- 1984-05-23
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- KRB
- Device class
- 2
- Regulation number
- 870.1915
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.