BICARB MIXING AND DISTRIBUTION SYSTEM— 510(k) K112427
Substantially EquivalentIsopure, Corp.
FDA 510(k) clearance K112427 for BICARB MIXING AND DISTRIBUTION SYSTEM, Substantially Equivalent on 2012-01-26. Applicant: Isopure, Corp.. Device class: 2.
Clearance details
- Applicant
- Isopure, Corp.
- Product code
- Code FIN
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Simpsonville, KY, US
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More clearances from Isopure, Corp.
view allRecalls naming K112427
K-number listed on FDA's recall record- Z-1360-2022 — Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
- Z-0822-2020 — Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112427.
Data sourced from openFDA. This site is unofficial and independent of the FDA.