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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K961903
Device Name MAGELLAN
Applicant
Biosense, Ltd.
Pob 297, Etgar St.
Einstien Bldg.
Tirat Hacarmel,  IL 39101
Applicant Contact SUSAN J ZACHMAN
Correspondent
Biosense, Ltd.
Pob 297, Etgar St.
Einstien Bldg.
Tirat Hacarmel,  IL 39101
Correspondent Contact SUSAN J ZACHMAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received05/16/1996
Decision Date 08/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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