AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV— 510(k) K121022
Substantially EquivalentAmeriwater
FDA 510(k) clearance K121022 for AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV, Substantially Equivalent on 2012-09-17. Applicant: Ameriwater. Device class: 2.
Clearance details
- Applicant
- Ameriwater
- Product code
- Code FIP
- Device class
- Class 2
- Regulation
- 21 CFR 876.5665
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dayton, OH, US
Recent devices under product code FIP
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view all- K141213 — AMERIWATER OZONE DISINFECTION SYSTEM
- K142285 — AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
- K133783 — AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION
- K131904 — MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA
- K131622 — MROZ REVERSE OSMOSIS SYSTEM
Adverse events under product code FIP
product code FIP- Malfunction
- 490
- Total
- 490
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.