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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobinometer
510(k) Number K933836
Device Name HBM HEMOGLOBINOMETER
Applicant
Artel, Inc.
12 Depot St.
Windham,  ME  04062
Applicant Contact CHARLES EWING
Correspondent
Artel, Inc.
12 Depot St.
Windham,  ME  04062
Correspondent Contact CHARLES EWING
Regulation Number864.7500
Classification Product Code
GIG  
Date Received08/05/1993
Decision Date 03/31/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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