510(k) K202375
- Device
- ZOLL Propaq M
- Applicant
- ZOLL Medical Corporation
- 510(k) number
- K202375
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-09
- Date received
- 2020-08-20
- 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
- Elizabeth McMeniman
- Address
- 269 Mill Rd. Chelsmford MA US 01824 01824
FDA Registration Numbers#
- 3009831876
- 3012528160
- 3013557562
- 3009077524
- 8020045
- 3000976525
- 3003832357
- 3007029079
- 3007413079
- 3010120135
- 9615102
- 3021632375
- 3005053560
- 3000126629
- 3034603598
- 3014856521
- 3009959868
- 3006733253
- 3016670256
- 3016931915
- 8040564
- 3013188547
- 1316463
- 3006648320
- 1527715
- 3004415095
- 3029871637
- 3003294644
- 3010419931
- 9681548
- 3006808382
- 8021084
- 8043459
- 1066270
- 9610816
- 8030229
- 3002736372
- 3043668257
- 3024491912
- 3011353843
- 3004188066
- 3009156722
- 3006979678
- 3010317211
- 3043543260
- 3004906872
- 3020476987
- 3007615597
- 3003971136
- 3016674095
- 3011200896
- 3011683100
- 1930027
- 9616760
- 3010120148
- 3009327812
- 3030447506
- 3004009431
- 3010399798
- 3022425463
- 3010032903
- 3007481893
- 1054713
- 3004145393
- 3008977358
- 3009673645
- 3003630387
- 2520313
- 3006606827
- 3008164770
- 3016618143
- 3010824458
- 3006546174
- 3003591740
- 3008255748
- 3003589956
- 3033959233
- 3010157426
- 3009499478
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 |