USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
FDA 510(k) clearance K031502 · decided 2004-08-27
Clearance details
- K-number
- K031502
- Device name
- USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM
- Applicant
- Usfilter
- Decision
- Substantially Equivalent
- Date received
- 2003-05-13
- Decision date
- 2004-08-27
- Days to decision
- 472 days
- Clearance type
- Traditional
- Product code
- FIN
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Colorado Springs, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.