Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K220290 |
Device Name |
Revitalair 430+ |
Applicant |
US Hyperbaric Network |
7600 NW 69th Ave |
Medley,
FL
33166
|
|
Applicant Contact |
Jorge Millan |
Correspondent |
US Hyperbaric Network |
7600 NW 69th Ave |
Medley,
FL
33166
|
|
Correspondent Contact |
Jorge Millan |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 02/01/2022 |
Decision Date | 05/04/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|