Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K180902 |
Device Name |
MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly |
Applicant |
MediPines Corporation |
155 N Riverview Drive |
Anaheim,
CA
92808
|
|
Applicant Contact |
Steve Lee |
Correspondent |
MediPines Corporation |
155 N. Riverview Drive |
Anaheim Hill,
CA
92808
|
|
Correspondent Contact |
Timothy Marcum |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/06/2018 |
Decision Date | 01/11/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|