FDA 510(k), K121197, BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
FDA 510(k), K121197, BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
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510(K) Number: K121197
Device Name: BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Manufacturer: DREW PALIN
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: 04/19/2012
Date Received: 08/10/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
Manufacturer: DREW PALIN
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: DSI
Classification Product Code: 04/19/2012
Date Received: 08/10/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular