510(k) K213863
- Device
- Everion+ System
- Applicant
- Biofourmis Singapore Pte., Ltd.
- 510(k) number
- K213863
- Product code
- MSX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-23
- Date received
- 2021-12-10
- Regulation
- 870.2300
- Classification name
- System, Network And Communication, Physiological Monitors
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Milan Shah
- Address
- 2 Venture Dr., Vision Exchange, #07-15 Singapore SG 608526 608526
FDA Registration Numbers#
- 3007413079
- 3001104093
- 2080783
- 3008855170
- 3012528160
- 9611500
- 3007603826
- 3013596024
- 3004526608
- 3004906872
- 3009973336
- 3013500228
- 3001570235
- 1000122786
- 3009156722
- 3000976525
- 3009831876
- 9610816
- 9680215
- 3013501110
- 3015134004
- 3010703925
- 3019388613
- 3014541700
- 3010157426
- 3012359877
- 3009443693
- 3018188848
- 3009673645
- 1651104
- 3013783488
- 3027510187
- 3003971136
- 3013896610
- 3007481893
- 3016701404
- 1316463
- 2032233
- 3009499478
- 3014856521
- 3016618143
- 3009077524
- 3008952681
- 3015437214
- 3015529350
- 1218950
- 9611252
- 3016852448
- 3008729547
- 3011696573
- 3008058135
- 3011353843
- 9681377
- 3009595635
- 3010698831
- 3013546957
- 3011166598
- 3005783425
- 9610105
- 3000126629
- 8020045
- 3003263092
- 3004091281
- 2221819
- 3006104191
- 1831750
- 3016670256
- 3015173634
- 3006240053
- 2183613
Source Documents#
Other 510(k) Records For Product Code MSX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | 2026-03-30 |
| K243270 | TigerConnect Alarm Management | Tigerconnect | 2025-09-30 |
| K242728 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-07-31 |
| K242750 | Central Station | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| K242842 | ANNE View, Central Hub | Sibel Health, Inc. | 2025-01-08 |
| K241397 | Hinscope | Hinlab Sas | 2024-11-14 |
| K233834 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2024-07-12 |
| K233418 | Biofourmis Everion+ (G2) | Biofourmis Singapore Pte., Ltd. | 2024-05-09 |
| K232548 | Corsano CardioWatch 287-2 System | Corsano Health B.V. | 2024-03-22 |
| K231506 | Current Health System | Current Health , Ltd. | 2023-08-24 |
| K223567 | CNS-2101 Central Monitor | Nihon Kohden Corporation | 2023-07-31 |
| K222550 | Current Health System | Current Health , Ltd. | 2022-11-01 |
| K203579 | Infinity Gateway Suite | Draeger Medical Systems, Inc. | 2022-06-07 |
| K211046 | eCareManager 4.5 | Visicu, Inc. | 2022-06-03 |
| K220058 | BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 |