510(k) K201590
- Device
- EMMA Capnograph
- Applicant
- Masimo Corporation
- 510(k) number
- K201590
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-29
- Date received
- 2020-06-12
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Katelynn Kirby
- Address
- 52 Discovery Irvine CA US 92618 92618
FDA Registration Numbers
- 2221819
- 3005877899
- 9710602
- 3006061749
- 1218950
- 1061124
- 3032109181
- 1722070
- 3013513837
- 3006733253
- 3009156722
- 3016701404
- 3007695715
- 3005135175
- 3009077524
- 3009001657
- 1650347
- 3006648320
- 3013826848
- 9710116
- 8044169
- 2183646
- 3015997711
- 2648727
- 3018783526
- 3010390468
- 3005998497
- 3004055954
- 3013557562
- 3010887638
- 3006536657
- 3008716327
- 8044004
- 3003879246
- 8021995
- 3011987967
- 1423537
- 8030229
- 3012307300
- 9617566
- 3007481893
- 3013298431
- 3012834717
- 2529489
- 3010526986
- 3012733231
- 1000604079
- 3012337868
- 2023529
- 3006713849
- 3011120183
- 1024404
- 3003674698
- 9615102
- 8020864
- 9617192
- 3006547005
- 2080783
- 3030733800
- 3004050971
- 3010157426
- 3002807267
- 1450653
- 3008058135
- 9710644
- 3016964847
- 3017609572
- 3009973336
- 3006534321
- 1043214
- 1066270
- 3035111606
- 3017844574
- 3008729547
- 3012421607
- 3013679558
- 1000484830
- 3007413079
- 3016618143
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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