Device Classification Name |
Generator, Oxygen, Portable
|
510(k) Number |
K200496 |
Device Name |
Aer X |
Applicant |
3B Medical Inc. |
203 Avenue A NW, Suite 300 |
Winter Haven,
FL
33881
|
|
Applicant Contact |
Yasser Estafanous |
Correspondent |
3B Medical Inc. |
203 Avenue A NW, Suite 300 |
Winter Haven,
FL
33881
|
|
Correspondent Contact |
Yasser Estafanous |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 02/28/2020 |
Decision Date | 07/24/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|