Device Classification Name |
Mixer, Breathing Gases, Anesthesia Inhalation
|
510(k) Number |
K202480 |
Device Name |
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 |
Applicant |
Parker Hannifin |
245 Township Line Road |
Hatfield,
PA
19440
|
|
Applicant Contact |
Andrew Ellinger |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
Dave Yungvirt |
Regulation Number | 868.5330
|
Classification Product Code |
|
Date Received | 08/28/2020 |
Decision Date | 04/22/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|