Medical Device Manufacturer · US , Dayton , OH

Ameriwater - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2000

11

Total

11

Cleared

0

Denied

Ameriwater — FDA 510(k) Products and Clearance History Gastroenterology & Urology ✕

11 devices

1-11 of 11

Cleared Dec 10, 2014

AMERIWATER OZONE DISINFECTION SYSTEM

Gastroenterology & Urology · 212d

Cleared Dec 01, 2014

AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V,...

Gastroenterology & Urology · 105d

Cleared Apr 16, 2014

AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION

Gastroenterology & Urology · 125d

Cleared Nov 13, 2013

MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA...

Gastroenterology & Urology · 141d

Cleared Sep 20, 2013

MROZ REVERSE OSMOSIS SYSTEM

Gastroenterology & Urology · 109d

Cleared Sep 17, 2012

AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH...

Gastroenterology & Urology · 166d

Cleared Oct 05, 2011

AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION

Gastroenterology & Urology · 106d

Cleared Jan 06, 2006

AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS

Gastroenterology & Urology · 259d

Cleared Aug 14, 2003

MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Gastroenterology & Urology · 458d

Cleared Apr 07, 2003

PORTABLE RO+ MODEL MROS09

Gastroenterology & Urology · 90d

Cleared Apr 14, 2000

AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

Gastroenterology & Urology · 350d