Airstrip RPM for Lifenet Consult
FDA 510(k) K121712 · Airstrip Technologies, Inc.
510(k) numberK121712
Submission
- Device name
- Airstrip RPM for Lifenet Consult
- Applicant
- Airstrip Technologies, Inc.
San Antonio, TX, US - Received
- June 11, 2012
- Decision date
- November 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code MSX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261287 | Digistat CareMSX · Traditional | Ascom Ums Srl Unipersonale | 09/12/2026SE |
| K260211 | Dashboard (P007000)MSX · Traditional | Hill-Rom, Inc. | 08/13/2026SE |
| K261367 | Corsano CardioWatch 287-2 SystemMSX · Traditional | Corsano Health B.V. | 07/26/2026SE |
| K253654 | IntelliVue Measurement Rack 6000 (867317)MSX · Traditional | Philips Medizin Systeme Böblingen GmbH | 03/30/2026SE |
| K243270 | TigerConnect Alarm ManagementMSX · Traditional | Tigerconnect | 09/30/2025SE |
| 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 |
| K242842 | ANNE View, Central HubMSX · Traditional | Sibel Health, Inc. | 01/08/2025SE |
| K241397 | HinscopeMSX · Traditional | Hinlab Sas | 11/14/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | Draeger Medical Systems, Inc. | 07/12/2024SE |
More from Draeger Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K211949 | AirStrip ONE Web Client with Alarm Communication Management (ACM)MSX · Special | 12/09/2021SE |
| K182226 | AirStrip RPM InvisionHeart AdapterMWI · Traditional | 09/11/2018SE |
| K160862 | AirStrip RPMMSX · Traditional | 09/19/2016SE |
| 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 |
| 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 RPM for Lifenet Consult cleared by the FDA?
Airstrip RPM for Lifenet Consult (K121712) received a 510(k) decision of Substantially Equivalent on November 20, 2012, 162 days after the submission was received.
What is the product code of K121712?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.