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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K842220
Device Name MULTILITH 2 PULSE GENERATOR 1141 & 2141
Applicant
Ela Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact Tom Anderson
Correspondent
Ela Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact Tom Anderson
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/05/1984
Decision Date 11/29/1984
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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