Infinity Gateway Suite
FDA 510(k) K203579 · Draeger Medical Systems, Inc.
510(k) numberK203579
Submission
- Device name
- Infinity Gateway Suite
- Applicant
- Draeger Medical Systems, Inc.
Andover, MA, US - Received
- December 7, 2020
- Decision date
- June 7, 2022
- 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 |
|---|---|---|
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | 08/20/2026SE |
| K243606 | Babyroo TN300FMT · Traditional | 01/17/2025SE |
| K240312 | Infinity CentralStation WideMHX · Traditional | 08/01/2024SE |
| K233834 | Infinity Gateway SuiteMSX · Traditional | 07/12/2024SE |
| K231477 | Infinity CentralStation Wide, Infinity M300, Infinity M300+MHX · Traditional | 10/17/2023SE |
| K230278 | Babyroo TN300FMT · Traditional | 05/30/2023SE |
| K203088 | Infinity Acute Care System (IACS) Monitoring SystemMHX · Traditional | 02/01/2022SE |
| K201764 | Infinity Acute Care System (IACS) Monitoring SolutionMHX · Traditional | 12/09/2021SE |
| K200859 | Infinity M300MHX · Traditional | 08/28/2020SE |
| K182977 | Isolette 8000 PlusFMZ · Special | 11/21/2018SE |
Questions and answers
When was Infinity Gateway Suite cleared by the FDA?
Infinity Gateway Suite (K203579) received a 510(k) decision of Substantially Equivalent on June 7, 2022, 547 days after the submission was received.
What is the product code of K203579?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.