Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K211171 |
Device Name |
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories |
Applicant |
GE Healthcare Finland Oy |
Kuortaneenkatu 2 |
Helsinki,
FI
FI-00510
|
|
Applicant Contact |
Joel Kent |
Correspondent |
GE Healthcare Finland Oy |
Kuortaneenkatu 2 |
Helsinki,
FI
FI-00510
|
|
Correspondent Contact |
Joel Kent |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/19/2021 |
Decision Date | 10/21/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|