510(k) K253196
- Device
- Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
- Applicant
- Midmark Corporation
- 510(k) number
- K253196
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-12
- Date received
- 2025-09-26
- 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
- N
Applicant Contact#
- Contact
- Jessica Hembrey
- Address
- 60 Vista Dr. Versailles OH US 45380 45380
FDA Registration Numbers#
- 2520313
- 3003832357
- 3010392999
- 3003681187
- 3013298431
- 3016701404
- 3008977358
- 3010317211
- 3000976525
- 3014579161
- 1066270
- 3004188066
- 9681548
- 3010419931
- 3008253300
- 3011359729
- 3011651230
- 3015142815
- 9611252
- 3016674095
- 3012359877
- 3023412068
- 8021084
- 3007603826
- 3034603598
- 2027454
- 1220908
- 9610816
- 3006808382
- 3009831876
- 3006104191
- 3006546174
- 9610105
- 3009156722
- 3037341611
- 3033959233
- 3007029079
- 1930027
- 3008716327
- 2032233
- 3005803793
- 3008255748
- 2936999
- 3035111606
- 3003174284
- 3013500228
- 3011353843
- 3014886121
- 8040564
- 3008787503
- 3010032903
- 3011200896
- 3005521864
- 3021343210
- 1316463
- 3010120148
- 3010824458
- 3018094310
- 3008729547
- 3013896610
- 1222630
- 3027256461
- 3047896295
- 3012421607
- 3013596024
- 3043543260
- 3018514222
- 3003768277
- 3006240053
- 3005569927
- 3010157426
- 2952596
- 3012238587
- 1066427
- 3007615597
- 1051786
- 3019834104
- 3012103976
- 8010482
- 3009959868
Source Documents#
Other 510(k) Records For Product Code MWI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2) | Infinium Medical, Inc. | 2026-08-14 |
| K253417 | Masimo Root Monitoring System | Masimo Corporation | 2026-08-12 |
| 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 |