Device Classification Name |
chamber, hyperbaric
|
510(k) Number |
K041007 |
Device Name |
MILLENIUM, MODELS 2000, 2001 AND 2002 |
Applicant |
HYPERBARIC FOR LIFE LLC |
3206 WEST STATE AVE. |
PHOENIX,
AZ
85051
|
|
Applicant Contact |
RICK RYDER |
Correspondent |
HYPERBARIC FOR LIFE LLC |
3206 WEST STATE AVE. |
PHOENIX,
AZ
85051
|
|
Correspondent Contact |
RICK RYDER |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 04/19/2004 |
Decision Date | 11/15/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|