510(k) K120193
- Device
- ANY VIEW PATIENT MONITORS
- Applicant
- GUANGDONG BIOLIGHT MEDITECH CO., LTD
- 510(k) number
- K120193
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-06-29
- Date received
- 2012-01-23
- Regulation
- 870.2300
- Classification name
- Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Diana Hong
- Address
- P.O. Box 237-023 Shanghai CN 200237 200237
FDA Registration Numbers#
- 8030229
- 3004091281
- 3036798186
- 3012251275
- 3034603598
- 3009156722
- 3016670256
- 3010863450
- 3003630387
- 3003832357
- 3014856521
- 3001570235
- 3037341611
- 1222630
- 3009499478
- 3013896610
- 3011353843
- 1527715
- 3005803793
- 3016674095
- 8010482
- 3000126629
- 2221819
- 3010392999
- 3021219789
- 3010419931
- 3003591740
- 3010041430
- 3007029079
- 2936999
- 1220908
- 3031563234
- 3003768277
- 9681548
- 3042175844
- 3015529350
- 3016618143
- 3030447506
- 3010120135
- 3018094310
- 3008283443
- 3016852448
- 3013298431
- 3006979678
- 1066270
- 9611252
- 3006240053
- 3004145393
- 1000122786
- 8040564
- 2952596
- 3008716327
- 8022257
- 1054713
- 1316463
- 3032013079
- 3008164770
- 3038259592
- 3006606827
- 9615102
- 3008253300
- 3013188547
- 3004906872
- 3008255748
- 3010824458
- 3014886121
- 3015142815
- 8043459
- 3007836437
- 3003681187
- 3006146787
- 3012359877
- 3043543260
- 8040537
- 3022425463
- 3007137598
- 1062836
- 3033959233
- 3009077524
Source Documents#
Other 510(k) Records For Product Code MWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253196 | Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400) | Midmark Corporation | 2026-06-12 |
| K253436 | c-med0 alpha | Cosinuss GmbH | 2026-04-30 |
| K250135 | WAVE Clinical Platform (2.0.000) | Baxter Healthcare Corp/ Excel Medical | 2026-01-16 |
| K241766 | QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) | Fysicon BV | 2025-08-27 |
| K242737 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2025-06-06 |
| K241958 | WARD-CSS (v1.2.x) | Ward 24/7 Aps | 2025-02-14 |
| K243146 | iCare APP | Ihealth Labs, Inc. | 2025-02-03 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024-12-20 |
| K243216 | Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) | Analog Devices | 2024-12-10 |
| K233446 | AMC Health CareConsole | Amc Health | 2024-09-27 |
| K240236 | Happy Ring Health Monitoring System | Happy Health, Inc. | 2024-09-24 |
| K233354 | WVSM Pro (Series) (500-0030-XX) | Athena Gtx, Inc. | 2024-06-26 |
| K232111 | NeoBeat, NeoBeat Mini | Laerdal Medical AS | 2024-06-25 |
| K233810 | Portrait VSM | Ge Medical Systems Information Technologies, Inc. | 2024-04-25 |
| K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | Talis Clinical, LLC | 2024-04-01 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases