Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
510(k) Number |
K181467 |
Device Name |
Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line |
Applicant |
Oridion Medical 1987 Ltd. |
7 Hamarpe Street P.O. Box 45025 |
Jerusalem,
IL
9777407
|
|
Applicant Contact |
Dalia Givony |
Correspondent |
Oridion Medical 1987 Ltd. |
7 Hamarpe Street P.O. Box 45025 |
Jerusalem,
IL
9777407
|
|
Correspondent Contact |
Dalia Givony |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 06/04/2018 |
Decision Date | 02/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|