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Records – FDA 510(k) Submission K172959
Records – FDA 510(k) Submission K172959
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510(K) Number: K172959
Device Name: PeraServer and PeraTrend
Manufacturer: PeraHealth, Inc.
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 09/26/2017
Decision Date: 05/01/2018
Regulation Medical Specialty: Cardiovascular
Request Contents: Records related to FDA 510(k) submission K172959.
Device Name: PeraServer and PeraTrend
Manufacturer: PeraHealth, Inc.
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 09/26/2017
Decision Date: 05/01/2018
Regulation Medical Specialty: Cardiovascular
Request Contents: Records related to FDA 510(k) submission K172959.
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