Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1530185

FEI Number

1000515504

Entity Name

AMERIWATER LLC.

City/State/Country

DAYTON, OH, US

Establishment Address

3345 Stop 8 Rd, Suite A, DAYTON, OH 45414, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

AMERIWATER LLC (Owner Number: 9009428)

Owner / Operator Contact Address

3345 Stop 8 Rd, --, Dayton, OH 45414, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141213

PMA Number

N/A

All Registered Proprietary Names

AmeriWater Alarm Panel AmeriWater MROZ Reverse Osmosis System AMERIWATER WATER P AmeriWater Centurion Reverse Osmosis System AmeriWater MRO Portable RO System AsepTech Portable RO+ System AmeriWater MediQA Reverse Osmosis System, Model MSP3HF AMERIWATER SOLUTION MIX AmeriWater Heatsan AmeriWater MediQA Reverse Osmosis System AmeriWater Ozone Disinfection System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2012-10-12
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2013-10-31
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	1994-02-03
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2014-12-17
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2011-11-18
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2013-10-31
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2023-03-08
FIN	Tank, Holding, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2006-06-08
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2014-12-17
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2014-12-17
FIN	Tank, Holding, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2014-12-17

Official Correspondent

BRIAN BOWMAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AMERIWATER LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110578	Mar Cor Purification, Inc.	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	2011-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-05	Ameriwater Inc	2	AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number	Establishment Name	Location
3010867648	NELSON ENVIRONMENTAL TECHNOLOGIES, INC.	Arlington, TX, US
2135346	CULLIGAN SOFT WATER SERVICE CO.	Minnetonka, MN, US
3015349756	DIALITY, INC.	Irvine, CA, US
3003550196	Veolia Water Treatment & Solutions	ARLINGTON, TX, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1530185. Last updated year: 2026. Please use registration number 1530185 when referencing this establishment in official correspondence.