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FDA 510(k) Application Details - K981563
Device Classification Name
Device, Muscle Monitoring
More FDA Info for this Device
510(K) Number
K981563
Device Name
Device, Muscle Monitoring
Applicant
BIO-RESEARCH ASSOCIATES, INC.
4113 NORTH PORT WASHINGTON RD.
MILWAUKEE, WI 53212 US
Other 510(k) Applications for this Company
Regulation Number
890.1375
More FDA Info for this Regulation Number
Classification Product Code
KZM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/1998
Decision Date
09/15/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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