510(k) K213767
- Device
- Endure ETCO2/02 Nasal Cannula
- Applicant
- Endure Industries, Inc.
- 510(k) number
- K213767
- Product code
- CCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-12
- Date received
- 2021-12-01
- Regulation
- 868.1400
- Classification name
- Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Manoj Kumar
- Address
- 45 N Fulton St. Homer NY US 13077 13077
FDA Registration Numbers
- 3010272829
- 3015272694
- 9710602
- 1423537
- 3004906872
- 3011987967
- 3003898360
- 3003674698
- 1000484830
- 3027256461
- 3014541700
- 3008716327
- 3013501110
- 3019388613
- 3003630387
- 3008363989
- 3006807694
- 3010157426
- 3017609572
- 1062836
- 3013783488
- 1319447
- 3006547005
- 3003832357
- 3011503227
- 3005587132
- 8022257
- 3009499478
- 3004977335
- 1066270
- 2023529
- 3009001657
- 3006648320
- 3015997711
- 9617604
- 3017202422
- 9616088
- 3018094310
- 8030673
- 3003879246
- 9617566
- 3004415070
- 2183646
- 3030154814
- 1319639
- 3009754460
- 3018783526
- 3003800159
- 3007695715
- 8021995
- 3016964847
- 3013652261
- 3005873568
- 3007048256
- 3003591740
- 9611500
- 3013596024
- 9710644
- 3001313714
- 3006606984
- 3013500228
- 3014479313
- 3013679558
- 9610816
- 3010149039
- 3010703925
- 3011120183
- 3010411911
- 3007238566
- 1024404
- 2134752
- 3024706751
- 3009490946
- 3010223399
- 3010419931
- 3004111573
- 3007836437
- 3005877899
- 3008483389
Source Documents
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