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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name amplifier and signal conditioner, transducer signal
510(k) Number K010640
Device Name SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Applicant Contact PENELOPE H GRECO
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS,  MA  01923
Correspondent Contact PENELOPE H GRECO
Regulation Number870.2060
Classification Product Code
DRQ  
Date Received03/05/2001
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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