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
- N
Related Records
Applicant Contact
- Contact
- Phani Puppala
- Address
- 1 Analog Way Wilmington MA US 02038 02038
FDA Registration Numbers
- 2221819
- 9710602
- 3004009431
- 3007615597
- 3031563234
- 3003174284
- 2027454
- 1054713
- 3004145393
- 8040537
- 3008977358
- 3006733253
- 3009156722
- 3010041430
- 3016701404
- 1066427
- 3013188547
- 3009077524
- 3004091281
- 3007137598
- 3009001657
- 3006648320
- 1051786
- 3011683100
- 1833920
- 3030447506
- 3010390468
- 3013557562
- 3008716327
- 3010399798
- 3003294644
- 3010032903
- 8030229
- 3008164770
- 3007481893
- 8020045
- 3013298431
- 3015142815
- 3012238587
- 3009673645
- 3005569927
- 3005803793
- 3006808382
- 3010392999
- 9615102
- 1221108
- 2080783
- 3036798186
- 3010157426
- 3010863450
- 3014856521
- 3015529350
- 8021084
- 1066270
- 3035111606
- 3010097171
- 3018514222
- 8040564
- 3009503584
- 3008729547
- 3012421607
- 3037341611
- 3007413079
- 1058584
- 3016618143
- 3006546174
- 3014886121
- 3027256461
- 3007603826
- 8043459
- 8010482
- 3003768277
- 3004906872
- 3010120135
- 3012528160
- 3003832357
- 2936999
- 3000976525
- 3014579161
Source Documents
510(k) summary PDF not indicated by FDA
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