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FDA 510(k), K083271, BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
FDA 510(k), K083271, BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
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510(K) Number: K083271
Device Name: BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
Manufacturer: JACK COGGAN
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 11/06/2008
Decision Date: 12/24/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY
Manufacturer: JACK COGGAN
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: KXA
Date Received: 11/06/2008
Decision Date: 12/24/2008
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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