Wearable Device, Wearable Package
FDA 510(k) K191272 · Current Health , Ltd.
510(k) numberK191272
Submission
- Device name
- Wearable Device, Wearable Package
- Applicant
- Current Health , Ltd.
Edinburgh, GB - Received
- May 13, 2019
- Decision date
- July 12, 2019
- 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 |
|---|---|---|
| K231506 | Current Health SystemMSX · Special | 08/24/2023SE |
| K222550 | Current Health SystemMSX · Special | 11/01/2022SE |
| K210133 | Current Health Monitoring System Gen 2 (G2)MSX · Traditional | 09/03/2021SE |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…MSX · Traditional | 03/27/2019SE |
Questions and answers
When was Wearable Device, Wearable Package cleared by the FDA?
Wearable Device, Wearable Package (K191272) received a 510(k) decision of Substantially Equivalent on July 12, 2019, 60 days after the submission was received.
What is the product code of K191272?
The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.