Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K190824 |
Device Name |
Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric |
Applicant |
Bluepoint Medical GmbH & Co. KG |
An der Trave 15 |
Selmsdorf,
DE
23923
|
|
Applicant Contact |
Bernd Lindner |
Correspondent |
Imagenix, Inc. |
S65 W35739 Piper Road |
Eagle,
WI
53119
|
|
Correspondent Contact |
Stephen Gorski |
Regulation Number | 868.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/01/2019 |
Decision Date | 12/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|