OXIMETER TO MEASURE HEMOGLOBIN MANUFACTURED BY OPTIMA, INC.

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Request for Information Form	Contact Information
Company Name	OPTIMA, INC.
Address	ROGIE BLDG. 5F, 1-48-11 ITABASHI, ITABASHI-KU
City, State, Zip	TOKYO,
Country	JA
FDA Owner/Operator Phone	81-353-752351
FDA Medical Specialty Code	HE - Hematology
FDA Product Code	GLY
FDA Classification Name	OXIMETER TO MEASURE HEMOGLOBIN
FDA Device Classification Code	Standards
FDA Regulation Number	864.7500
FDA Common Generic Name	OXIMETER TO MEASURE HEMOGLOBIN
FDA Proprietary Device Name	OXIMETER TO MEASURE HEMOGLOBIN
FDA Owner / Operator Number	9031133
FDA Owner / Operator Name	OPTIMA, INC.
FDA Establishment Registration Number	3004029547
FDA Registered Establishment Name	OPTIMA, INC.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	07-17-97
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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1	DEPUY-NEW BEDFORD, DIV. OF DEPUY ORTHOPAEDICS INC. NEW BEDFORD INDUSTRIAL PARK NEW BEDFORD, MA 02745 US 574-267-8143 4906 / 574-371-4906	MULTIPLE	INSTRUMENTS
2	INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. LEXINGTON, MA 02421 US 781-861-4467 / 781-861-4467	MULTIPLE: SYNTHESIS, 682, ETC.	OXIMETER TEST SYSTEM
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5	OPTI MEDICAL SYSTEMS INC. 235 HEMBREE PARK DRIVE ROSWELL, GA 30076 US 207-556-8155 / 770-510-4444 4466	AVL OPTI CRITICAL CARE ANALYZER	AUTOMATED BLOOD GAS/ ELECTROLYTE ANALYZER
6	ROCHE DIAGNOSTICS CORP. KRATKYSTRASSE 2 GRAZ, A-8020 AU 433-162-7787 / 43-316-277876560	AVL OMNI ANALYZER	AUTOMATED PH/BLOOD GAS/ELECTROLYTE/CO-OXIMETRY ANALYZER
7	TECHNOMART, INC. ACE-TECHNO TOWER II-307,#197-7 KURO-DONG, KURO-GU SEOUL, 152-848 KS 822-862-3434 / 847-758-8834	OPTIMA	OPTIMA
8	WATERS MEDICAL SYSTEMS, LLC 2112 15TH ST. N.W., SUITE A ROCHESTER, MN 55901 US 212-583-4920 / 507-252-3748	OXICOM-3000 WHOLE BLOOD OXIMETER	BLOOD OXIMETER