FDA 510(k), K100133, AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
FDA 510(k), K100133, AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
Device Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number: K100133
Device Name: AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
Applicant: AIRSTRIP TECHNOLOGIES, LP
Regulation Number: 870.2300
Classification Product Code: MWI
Date Received: 01/19/2010
Decision Date: 07/23/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total Pages: 398
Fully Redacted Pages: 67
Content Pages: 331
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