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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Programmer, Pacemaker
510(k) Number K884522
Device Name MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
Applicant
Teletronics, Inc.
Attorney-At-Law
40 Crane Hill Rd.
Suffield,  CT  06078
Applicant Contact C NEALON
Correspondent
Teletronics, Inc.
Attorney-At-Law
40 Crane Hill Rd.
Suffield,  CT  06078
Correspondent Contact C NEALON
Regulation Number870.3700
Classification Product Code
KRG  
Date Received10/27/1988
Decision Date 08/25/1989
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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