510(k) K243216
- Device
- Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
- Applicant
- Analog Devices
- 510(k) number
- K243216
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-10
- Date received
- 2024-10-03
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Phani Puppala
- Address
- 1 Analog Way Wilmington MA US 02038 02038
FDA Registration Numbers#
- 3035111606
- 8040564
- 3043543260
- 9610105
- 3010120135
- 3010419931
- 3033959233
- 3013188547
- 3010157426
- 3010692333
- 3016931915
- 3006733253
- 3010097171
- 3013501110
- 3006240053
- 3009001657
- 3003294644
- 2032233
- 3012238587
- 3010390468
- 2520313
- 3004009431
- 1833920
- 8030229
- 8040537
- 1066427
- 3006648320
- 3004091281
- 3029871637
- 3005803793
- 3004906872
- 3006979678
- 3012103976
- 3007481893
- 3003768277
- 3042175844
- 3010120148
- 2011171
- 1066270
- 3006808382
- 3018094310
- 3010716438
- 3008365372
- 2183613
- 8010482
- 3006606827
- 1058584
- 3015529350
- 8021084
- 3013596024
- 3031563234
- 9611348
- 3014128039
- 3007137598
- 8022257
- 3016852448
- 3003589956
- 3009673645
- 3005439460
- 3014579161
- 3020476987
- 1221108
- 2952596
- 9610816
- 3000126629
- 3006546174
- 3010399798
- 9680215
- 3003174284
- 3001570235
- 1220908
- 3005521864
- 3012933969
- 3012421607
- 3008716327
- 3021219789
- 9710602
- 3015142815
- 3008164770
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MWI#
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|---|---|---|---|
| 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 |
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| 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 |
| 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 |