FDA 510(k), K082327, INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
FDA 510(k), K082327, INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
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510(K) Number: K082327
Device Name: INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
Manufacturer: SOMANETICS CORP.
Device Classification Name: oximeter, tissue saturation
Regulation Number: 870.2700
Classification Product Code: MUD
Date Received: 08/14/2008
Decision Date: 04/03/2009
Regulation Medical Specialty: Cardiovascular
Device Name: INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C
Manufacturer: SOMANETICS CORP.
Device Classification Name: oximeter, tissue saturation
Regulation Number: 870.2700
Classification Product Code: MUD
Date Received: 08/14/2008
Decision Date: 04/03/2009
Regulation Medical Specialty: Cardiovascular