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#
- 3009327812
- 3017059349
- 3014579161
- 3008716327
- 3010390468
- 3010317211
- 3013298431
- 8030229
- 3014886121
- 3010032903
- 9611348
- 3013188547
- 3015142815
- 3018514222
- 8021084
- 3014128039
- 3036798186
- 3016674095
- 3038259592
- 2221819
- 1221108
- 1523530
- 9680215
- 3000126629
- 3011200896
- 3009959868
- 3012251275
- 3021343210
- 8022257
- 3004091281
- 3007603826
- 3012528160
- 1833920
- 3010157426
- 3010097171
- 3005053560
- 3008977358
- 3010716438
- 3007413079
- 3013501110
- 3003589956
- 3003832357
- 9615102
- 3008729547
- 3010120135
- 8010482
- 3003174284
- 3000130829
- 3029871637
- 3018094310
- 3016931915
- 3010419931
- 3008787503
- 9611252
- 3009499478
- 3010120148
- 3001570235
- 3009673645
- 3000976525
- 8040537
- 3004145393
- 3006546174
- 3006240053
- 3006146787
- 3008365372
- 3004009431
- 3012933969
- 3007137598
- 3008253300
- 8040564
- 3024491912
- 3020476987
- 3014856521
- 2027454
- 1062836
- 3009156722
- 3016852448
- 1066270
- 3011359729
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 |
| K253306 | BioTracker 2.0 | Biotracker, LLC | 2026-06-26 |
| 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 |
Legacy Summary#
summary
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