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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 K900213
Device Name PACEMAKER PATIENT ADAPTOR MODULE (PPAM)
Applicant
Bomed Medical Mfg., Ltd.
15 Musick
Irvine,  CA  92718
Applicant Contact BO SRAMEK
Correspondent
Bomed Medical Mfg., Ltd.
15 Musick
Irvine,  CA  92718
Correspondent Contact BO SRAMEK
Regulation Number870.2770
Classification Product Code
DSB  
Date Received01/17/1990
Decision Date 06/28/1990
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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