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AirStrip Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2829-2016Class IIAirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitorAugust 4, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K211949AirStrip ONE Web Client with Alarm Communication Management (ACM)December 9, 2021
K182226AirStrip RPM InvisionHeart AdapterSeptember 11, 2018
K160862AirStrip RPMSeptember 19, 2016
K143114Sense4Baby System Model B+ (MSA)March 10, 2015
K133450AIRSTRIP REMOTE PATIENT MONITORINGFebruary 14, 2014
K133394AIRSTRIP REMOTE PATIENT MONITORINGFebruary 6, 2014
K131786AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTERJuly 3, 2013
K121712AIRSTRIP RPM FOR LIFENET CONSULTNovember 20, 2012
K122133AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGOctober 2, 2012
K121871AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGJuly 3, 2012
K112235AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGAugust 26, 2011
K110503AIRSTRIP REMOTE PATIENT MONITORING (RPM)March 10, 2011
K100133AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1July 23, 2010
K090269AIRSTRIP OBFebruary 13, 2009
K090061AIRSTRIP OBJanuary 23, 2009