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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K850791
Device Name MDI 2000 - PULSE GENERATOR
Applicant
Micromedical Devices, Inc.
12741 E. Caley Ave.
Suite 128
Englewood,  CO  80111
Applicant Contact KAREN MURPHY
Correspondent
Micromedical Devices, Inc.
12741 E. Caley Ave.
Suite 128
Englewood,  CO  80111
Correspondent Contact KAREN MURPHY
Regulation Number870.5550
Classification Product Code
DRO  
Date Received02/26/1985
Decision Date 06/19/1985
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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