AirStrip Technologies, Inc.
FDA Regulatory Profile
AirStrip Technologies, Inc. appears in FDA public data with 1 recall, 15 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2829-2016, Class II) was initiated on Aug 4, 2016. Its most recent 510(k) clearance was granted on Dec 9, 2021.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2829-2016 | Class II | AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitor | Aug 4, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM) | Dec 9, 2021 |
| K182226 | AirStrip RPM InvisionHeart Adapter | Sep 11, 2018 |
| K160862 | AirStrip RPM | Sep 19, 2016 |
| K143114 | Sense4Baby System Model B+ (MSA) | Mar 10, 2015 |
| K133450 | AIRSTRIP REMOTE PATIENT MONITORING | Feb 14, 2014 |
| K133394 | AIRSTRIP REMOTE PATIENT MONITORING | Feb 6, 2014 |
| K131786 | AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER | Jul 3, 2013 |
| K121712 | AIRSTRIP RPM FOR LIFENET CONSULT | Nov 20, 2012 |
| K122133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Oct 2, 2012 |
| K121871 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Jul 3, 2012 |
| K112235 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING | Aug 26, 2011 |
| K110503 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) | Mar 10, 2011 |
| K100133 | AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1 | Jul 23, 2010 |
| K090269 | AIRSTRIP OB | Feb 13, 2009 |
| K090061 | AIRSTRIP OB | Jan 23, 2009 |