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510(k) K211949

AirStrip ONE Web Client with Alarm Communication Management (ACM) by Airstrip Technologies, Inc. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2021
Date Received
June 23, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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  • K131786 — AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER (July 3, 2013)
  • K121712 — AIRSTRIP RPM FOR LIFENET CONSULT (November 20, 2012)
  • K122133 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (October 2, 2012)
  • K121871 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (July 3, 2012)
  • K112235 — AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING (August 26, 2011)

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