Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K210019 |
Device Name |
Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ |
Applicant |
Unimed Medical Supplies, Inc. |
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan |
Shenzhen,
CN
518108
|
|
Applicant Contact |
Linbin Ye |
Correspondent |
Unimed Medical Supplies, Inc. |
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan |
Shenzhen,
CN
518108
|
|
Correspondent Contact |
Linbin Ye |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 01/04/2021 |
Decision Date | 03/04/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|