510(k) K131497
- Device
- MCKESSON CARDIOLOGY HEMO
- Applicant
- MCKESSON ISRAEL LTD.
- 510(k) number
- K131497
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-12-05
- Date received
- 2013-05-24
- 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
- PAUL SUMNER
- Address
- 5995 Windward Pkwy. Alpharetta GA US 30005 30005
FDA Registration Numbers#
- 2032233
- 9680215
- 3006546174
- 3003681187
- 2936999
- 3013557562
- 2520313
- 3032013079
- 3009156722
- 3012238587
- 9611348
- 3014128039
- 3008716327
- 3010041430
- 3020476987
- 3012494290
- 3014886121
- 3004091281
- 3006979678
- 3008729547
- 3012251275
- 3007481893
- 2221819
- 3006240053
- 3016674095
- 3006104191
- 3033715634
- 3015529350
- 3003589956
- 3043543260
- 9710602
- 3038259592
- 3010157426
- 3012421607
- 3010824458
- 1651104
- 3010419931
- 3006146787
- 1058584
- 3009327812
- 3016852448
- 8040537
- 3012528160
- 8040564
- 3010390468
- 3034603598
- 3008253300
- 3004009431
- 3009673645
- 3016931915
- 3010863450
- 3005569927
- 1221108
- 3003832357
- 8021084
- 3013298431
- 1222630
- 3006733253
- 3004188066
- 9610816
- 3011359729
- 3009959868
- 3033959233
- 3007836437
- 8022257
- 3036798186
- 3000130829
- 3006808382
- 8020045
- 3022425463
- 3005803793
- 3008977358
- 3010120148
- 1220908
- 3030447506
- 3014579161
- 3010692333
- 9610105
- 3007029079
- 3016701404
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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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