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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K861158
Device Name S&W TYPE 888 ELECTRODE
Applicant
National Medical Technology
Atlantic Bank Bldg.
20 N. Orange Ave.Suite 1400
Orlando,  FL  32801
Applicant Contact GEOFFREY R EISELE
Correspondent
National Medical Technology
Atlantic Bank Bldg.
20 N. Orange Ave.Suite 1400
Orlando,  FL  32801
Correspondent Contact GEOFFREY R EISELE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received03/28/1986
Decision Date 07/01/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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