HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
FDA 510(k) clearance K092481 · decided 2010-04-02
Clearance details
- K-number
- K092481
- Device name
- HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2
- Applicant
- New Aqua, LLC (Dba Aqua Systems)
- Decision
- Substantially Equivalent
- Date received
- 2009-08-13
- Decision date
- 2010-04-02
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Avon, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.