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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plethysmograph, Impedance
510(k) Number K880926
Device Name BIOLOGICAL OHM METER, BES 200Z
Applicant
Bioelectrical Sciences, Inc.
5580 La Jolla Blvd.
Suite 417
La Jolla,  CA  92037
Applicant Contact GLASSFORD
Correspondent
Bioelectrical Sciences, Inc.
5580 La Jolla Blvd.
Suite 417
La Jolla,  CA  92037
Correspondent Contact GLASSFORD
Regulation Number870.2770
Classification Product Code
DSB  
Date Received03/04/1988
Decision Date 06/15/1988
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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