Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K213767 |
Device Name |
Endure ETCO2/02 Nasal Cannula |
Applicant |
Endure Industries Inc |
45 N Fulton St |
Homer,
NY
13077
|
|
Applicant Contact |
Manoj Kumar |
Correspondent |
Endure Industries Inc |
45 N Fulton St |
Homer,
NY
13077
|
|
Correspondent Contact |
Manoj Kumar |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/01/2021 |
Decision Date | 09/12/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|