Aulisa Multiple Patient Digital Vital Sign Monitoring System
FDA 510(k) K202497 · Taiwan Aulisa Medical Devices Technologies, Inc.
510(k) numberK202497
Submission
- Device name
- Aulisa Multiple Patient Digital Vital Sign Monitoring System
- Applicant
- Taiwan Aulisa Medical Devices Technologies, Inc.
Taipei, TW - Received
- August 31, 2020
- Decision date
- October 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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 |
|---|---|---|
| K233963 | Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)DQA · Traditional | 02/25/2025SE |
| K233956 | Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)DQA · Traditional | 01/30/2025SE |
| K240220 | Aulisa Temperature Module (TM0002)FLL · Traditional | 09/27/2024SE |
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemDQA · Traditional | 06/12/2022SE |
| K191207 | Guardian Angel Rx GA2001 Digital Vital Sign Monitoring SystemDQA · Special | 06/25/2019SE |
| K183067 | Guardian Angel Rx GA2000 Digital Vital Sign Monitoring SystemDQA · Traditional | 03/01/2019SE |
| K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemDQA · Traditional | 03/01/2019SE |
| K162580 | Guardian Angel GA1000 Digital Vital Sign Monitoring SystemDQA · Traditional | 03/03/2017SE |
Questions and answers
When was Aulisa Multiple Patient Digital Vital Sign Monitoring System cleared by the FDA?
Aulisa Multiple Patient Digital Vital Sign Monitoring System (K202497) received a 510(k) decision of Substantially Equivalent on October 30, 2020, 60 days after the submission was received.
What is the product code of K202497?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.