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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 K864586
Device Name S&W ELECTRODE TYPES 888, 844, 988 AND 944
Applicant
S & W Medico Teknik
Haight, Gardner, Poor & Havens
One State St. Plz.
New York,  NY  10004
Applicant Contact LENNARD K RAMBUSCH
Correspondent
S & W Medico Teknik
Haight, Gardner, Poor & Havens
One State St. Plz.
New York,  NY  10004
Correspondent Contact LENNARD K RAMBUSCH
Regulation Number870.2360
Classification Product Code
DRX  
Date Received11/21/1986
Decision Date 03/13/1987
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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