Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K040145 |
Device Name |
ATA HCM MONOPLACE HYPERBARIC SYSTEM |
Applicant |
ATA HYPERBARIC CHAMBER MANUFACTURING |
695-ALPHA STREET |
VICTORIA, BC,
CA
|
|
Applicant Contact |
HUMPHREY KILLAM |
Correspondent |
ATA HYPERBARIC CHAMBER MANUFACTURING |
695-ALPHA STREET |
VICTORIA, BC,
CA
|
|
Correspondent Contact |
HUMPHREY KILLAM |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 01/22/2004 |
Decision Date | 05/04/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|