510(k) K193626
- Device
- Masimo Rad-97 Pulse CO-Oximeter and Accessories
- Applicant
- Masimo Corporation
- 510(k) number
- K193626
- Product code
- MWI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-10
- Date received
- 2019-12-26
- 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
Related Records
Applicant Contact
- Contact
- Linus Park
- Address
- 52 Discovery Irvine CA US 92618 92618
FDA Registration Numbers
- 9710602
- 3004906872
- 9681548
- 3027256461
- 3008716327
- 3013501110
- 3019388613
- 3003630387
- 2952596
- 3010157426
- 3014128039
- 3019834104
- 1062836
- 3010692333
- 1051786
- 3003832357
- 8022257
- 2520313
- 3009499478
- 3014856521
- 1066270
- 3009503584
- 3009001657
- 3006648320
- 3015529350
- 1222630
- 3033715634
- 3006146787
- 3018094310
- 2011171
- 3010863450
- 3003294644
- 3004091281
- 3003681187
- 3011651230
- 1523530
- 3042175844
- 3006240053
- 3010097171
- 2183613
- 3003591740
- 9611500
- 3013596024
- 3013500228
- 3010120148
- 3013188547
- 3000976525
- 9610816
- 9680215
- 8043459
- 3011683100
- 3007137598
- 3004009431
- 3009673645
- 8021084
- 2032233
- 8040564
- 3007029079
- 3010419931
- 3007836437
- 3004188066
- 1221108
- 3007615597
- 2027454
- 3016852448
- 3006808382
- 3011359729
- 3018514222
- 3024491912
- 3000130829
- 3010716438
- 3036798186
- 3003589956
- 3005521864
- 3008164770
- 8020045
- 2936999
- 3006104191
- 3016931915
- 3037341611
Source Documents
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