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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K041734
Device Name AMBU DISPOSABLE ECG ELECTRODE
Applicant
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090
Applicant Contact SANJAY PARIKH
Correspondent
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090
Correspondent Contact SANJAY PARIKH
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/25/2004
Decision Date 09/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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