BICARB MIXING AND DISTRIBUTION SYSTEM
FDA 510(k) clearance K112427 · decided 2012-01-26
Clearance details
- K-number
- K112427
- Device name
- BICARB MIXING AND DISTRIBUTION SYSTEM
- Applicant
- Isopure, Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-08-23
- Decision date
- 2012-01-26
- Days to decision
- 156 days
- Clearance type
- Special
- Product code
- FIN
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Simpsonville, KY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thomp recall (Z-0822-2020) | Isopure Corp | 2020-01-19 |