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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K852652
Device Name OMNIGRAPH 4000(ELECTROCARDIOGRAPH)
Applicant
Telemed Div.
2345 Pembroke Ave.
Hoffman Estates,  IL  60195
Applicant Contact SAMUEL L STANCER
Correspondent
Telemed Div.
2345 Pembroke Ave.
Hoffman Estates,  IL  60195
Correspondent Contact SAMUEL L STANCER
Regulation Number870.2850
Classification Product Code
DRS  
Date Received06/21/1985
Decision Date 11/19/1985
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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