AirStrip ONE Web Client with Alarm Communication Management (ACM)
FDA 510(k) K211949 · Airstrip Technologies, Inc.
510(k) numberK211949
Submission
- Device name
- AirStrip ONE Web Client with Alarm Communication Management (ACM)
- Applicant
- Airstrip Technologies, Inc.
San Antonio, TX, US - Received
- June 23, 2021
- Decision date
- December 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MSX – System, Network And Communication, Physiological Monitors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K242728 | BeneVision Central Monitoring SystemMSX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/31/2025SE |
| K242750 | Central StationMSX · Traditional | Nihon Kohden Digital Health Solutions, LLC | 06/05/2025SE |
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| K143114 | Sense4Baby System Model B+ (MSA)LQK · Traditional | 03/10/2015SE |
| K133450 | Airstrip Remote Patient MonitoringMWI · Special | 02/14/2014SE |
| K133394 | Airstrip Remote Patient MonitoringMWI · Traditional | 02/06/2014SE |
| K131786 | Airstrip Remote Patient Monitoring Philips AdapterMWI · Traditional | 07/03/2013SE |
| K121712 | Airstrip RPM for Lifenet ConsultMSX · Traditional | 11/20/2012SE |
| K122133 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingMWI · Special | 10/02/2012SE |
| K121871 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingMWI · Traditional | 07/03/2012SE |
| K112235 | Airstrip Remote Patient Monitoring (RPM) Remote Data ViewingMWI · Traditional | 08/26/2011SE |
Questions and answers
When was AirStrip ONE Web Client with Alarm Communication Management (ACM) cleared by the FDA?
AirStrip ONE Web Client with Alarm Communication Management (ACM) (K211949) received a 510(k) decision of Substantially Equivalent on December 9, 2021, 169 days after the submission was received.
What is the product code of K211949?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.