Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K031649 |
Device Name |
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES |
Applicant |
FINK ENGINEERING PTY LTD |
18111 COPPER RIDGE DRIVE |
SAN ANTONIO,
TX
78259
|
|
Applicant Contact |
W.T. WORKMAN |
Correspondent |
FINK ENGINEERING PTY LTD |
18111 COPPER RIDGE DRIVE |
SAN ANTONIO,
TX
78259
|
|
Correspondent Contact |
W.T. WORKMAN |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 05/28/2003 |
Decision Date | 12/05/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|