RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER
FDA 510(k) clearance K854806 · decided 1986-02-25
Clearance details
- K-number
- K854806
- Device name
- RAPID SOLUTION ADMIN SET W/INTEGRAL HEAT EXCHANGER
- Applicant
- Grant Medical Center
- Decision
- Substantially Equivalent
- Date received
- 1985-12-02
- Decision date
- 1986-02-25
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Columbus, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.