510(k) K190468
- Device
- Nihon Kohden SVM-7200 Series Vital Signs Monitor
- Applicant
- Nihon Kohden Corporation
- 510(k) number
- K190468
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-05-28
- Date received
- 2019-02-26
- 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
- Yes
Applicant Contact#
- Contact
- Thomas Bento
- Address
- 1-31-4 Nishiochiai, Shinjuku-Ku Tokyo JP 161-8560 161-8560
FDA Registration Numbers#
- 3033959233
- 3018094310
- 3010399798
- 9611348
- 3013298431
- 3008729547
- 1222630
- 3008716327
- 3003768277
- 3003589956
- 3009499478
- 3010824458
- 3007134734
- 3007137598
- 3012103976
- 3016852448
- 3003681187
- 3021632375
- 3035111606
- 1054713
- 3010390468
- 2027454
- 3016674095
- 3007029079
- 3008977358
- 3009156722
- 3004009431
- 3007413079
- 3016618143
- 3011651230
- 3012359877
- 3005569927
- 3013896610
- 3014856521
- 1066427
- 8040564
- 3006606827
- 3043543260
- 3042175844
- 3004091281
- 9610816
- 3027256461
- 2221819
- 3004188066
- 3003971136
- 3004415095
- 3015142815
- 3012421607
- 3015529350
- 2080783
- 3008787503
- 3010716438
- 3007305624
- 8021084
- 3007603826
- 3011359729
- 3005521864
- 1058584
- 3008255748
- 1527715
- 3000126629
- 3010392999
- 3012933969
- 8043459
- 3002736372
- 3009503584
- 3006648320
- 3003294644
- 3032013079
- 3013596024
- 3010863450
- 3003591740
- 3009001657
- 3003630387
- 3006146787
- 3011200896
- 3020476987
- 3008164770
- 3006808382
Source Documents#
Other 510(k) Records For Product Code MWI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260801 | Sensinel Cardiopulmonary Management (CPM) System | Analog Devices | 2026-10-16 |
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | 2026-08-14 |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026-08-12 |
| 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 |
Legacy Summary#
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
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