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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K960542
Device Name NOGA
Applicant
Biosense, Ltd.
Einstein Bldg., Etgar St.
New Industrial Area, Pob 297
Tirat Hacarmel, Haifa,  IL 39101
Applicant Contact SUSAN J ZACHMAN
Correspondent
Biosense, Ltd.
Einstein Bldg., Etgar St.
New Industrial Area, Pob 297
Tirat Hacarmel, Haifa,  IL 39101
Correspondent Contact SUSAN J ZACHMAN
Regulation Number870.1220
Classification Product Code
DRF  
Date Received02/07/1996
Decision Date 04/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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