PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
FDA 510(k) clearance K993272 · decided 2000-04-10
Clearance details
- K-number
- K993272
- Device name
- PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
- Applicant
- Pure Water, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-30
- Decision date
- 2000-04-10
- Days to decision
- 193 days
- Clearance type
- Traditional
- Product code
- FIN
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Anderson, SC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sodium Bicarbonate Mixing and Delivery System Software v 7.1. Model # MD-380, Serial Numbe recall (Z-0033-2012) | Isopure Corp | 2011-10-11 |