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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K842369
Device Name ELECATH INFANT ARTERIAL & VENOUS CANNU
Applicant
ELECTRO-CATHETER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ELECTRO-CATHETER CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5690
Classification Product Code
BWF  
Date Received06/15/1984
Decision Date 08/27/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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