Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K160630 |
Device Name |
Invacare Platinum Mobile Oxygen Concentrator |
Applicant |
INVACARE CORPORATION |
ONE INVACARE WAY |
ELYRIA,
OH
44035
|
|
Applicant Contact |
ELIJAH N. WREH |
Correspondent |
INVACARE CORPORATION |
ONE INVACARE WAY |
ELYRIA,
OH
44035
|
|
Correspondent Contact |
ELIJAH N. WREH |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 03/07/2016 |
Decision Date | 09/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|