Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009685433

FEI Number

3009685433

Entity Name

AMICO DIAGNOSTIC INCORPORATED

City/State/Country

Richmond Hill Ontario, CA

Establishment Address

122 East Beaver Creek Road, Richmond Hill Ontario L4B 1G6, CA

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Amico Diagnostic Incorporated (Owner Number: 10040947)

Owner / Operator Contact Address

122 East Beaver Creek Road, Richmond Hill, CA-ON L4B 4V1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K060649

PMA Number

N/A

All Registered Proprietary Names

MANUAL STETHOSCOPE - STHETHOSCOPES MULTIPLE & ACCESSORIES ELECTRONIC THERMOMETER OPHTHALMOSCOPES MULTIPLE & ACCESSORIES OPHTHALMOSCOPES - AC-POWERED BLOOD PRESSURE CUFFS & DEVICES INFRARED TYMPANIC ELECTRONIC THERMOMETER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2015-03-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-03-04
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2014-08-28
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2012-06-05
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-03-04

Official Correspondent

Jack Chang

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc. Email: usagent@ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

Amico Diagnostic Incorporated

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2018	Optovue, Inc.	2	iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue with Normative Database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Z-0010-2018	Optovue, Inc.	2	iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normative database is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue 500 with normative database is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009685433. Last updated year: 2026. Please use registration number 3009685433 when referencing this establishment in official correspondence.