FDA 510(k) Applications Submitted by Brian Ma

FDA 510(k) Number Submission Date Device Name Applicant
K121022 04/04/2012 AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV AMERIWATER
K141213 05/12/2014 AMERIWATER OZONE DISINFECTION SYSTEM AMERIWATER
K223656 12/06/2022 AmeriWater MediQA Reverse Osmosis System (MSP3HF) AmeriWater, Llc
K063390 11/09/2006 URINE CHEMISTRY ANALYZER UR-50 IND DIAGNOSTIC INC.
K201778 06/30/2020 i-STAT TBI Plasma cartridge with the i-STAT Alinity System Abbott Laboratories
K172851 09/20/2017 Microcyn Plus Antimicrobial Wound Care Solution Sonoma Pharmaceuticals, Inc.
K173896 12/22/2017 Microcyn Antimicrobial Hydrogel Sonoma Pharmaceuticals, Inc.
K963517 09/03/1996 SPECTRA SCIENCE BIOPSY FORCEPS SPECTRASCIENCE, INC.
K110118 01/18/2011 STIMTRODE SINGLE USE NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD.
K093591 11/19/2009 STIMPOD MODEL NMS-400 NERVE STIMULATOR XAVANT TECHNOLOGY (PTY), LTD.
K030687 03/05/2003 K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C KAMIYA BIOMEDICAL CO.
K050944 04/14/2005 K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET KAMIYA BIOMEDICAL CO.
K021660 05/20/2002 K-ASSAY LP(A) ASSAY KAMIYA BIOMEDICAL CO.
K022486 07/29/2002 K-ASSAY HS-CRP CONTROLS KAMIYA BIOMEDICAL CO.
K042241 08/19/2004 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C KAMIYA BIOMEDICAL CO.
K023828 11/18/2002 K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR KAMIYA BIOMEDICAL CO.
K023853 11/19/2002 K-ASSAY LP(A) CONTROLS KAMIYA BIOMEDICAL CO.
K131027 04/12/2013 MEMORY PUMP MODEL Y4947 TOMY INTERNATIONAL
K153648 12/21/2015 Microcyn Plus Skin and Wound Hydrogel OCULUS INNOVATIVE SCIENCES
K030059 01/07/2003 PORTABLE RO+ MODEL MROS09 AMERIWATER
K051031 04/22/2005 AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS AMERIWATER
K131622 06/03/2013 MROZ REVERSE OSMOSIS SYSTEM AMERIWATER
K111740 06/21/2011 AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION AMERIWATER
K131904 06/25/2013 MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA AMERIWATER
K142285 08/18/2014 AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz AmeriWater
K133783 12/12/2013 AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION AMERIWATER
K141012 04/21/2014 HYDROCLEANSE WOUND CARE SOLUTION OCULUS INNOVATIVE SCIENCES
K141352 05/23/2014 ENDOCYN ROOT CANAL IRRIGATION SOLUTION OCULUS INNOVATIVE SCIENCES
K131672 06/06/2013 MICROCYN SCAR MANAGEMENT HYDROGEL OCULUS INNOVATIVE SCIENCES
K143590 12/18/2014 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES
K161034 04/13/2016 Microcyn Plus Wound Care Solution OCULUS INNOVATIVE SCIENCES
K171727 06/12/2017 Hydrocleanse Antimicrobial Skin and Wound Care Solution Sonoma Pharmaceuticals
K171935 06/28/2017 Alevicyn SG Antimicrobial Gel Sonoma Pharmaceuticals, Inc.
K152055 07/24/2015 Ceramax Skin Barrier Cream OCULUS INNOVATIVE SCIENCES
K162217 08/08/2016 LOYON Oculus Innovative Sciences
K172622 09/01/2017 Microcyn Antimicrobial Skin and Wound Cleanser Sonoma Pharmaceuticals
K152945 10/06/2015 Alevicyn SG Antipruritic Gel OCULUS INNOVATIVE SCIENCES


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact