Device Classification Name |
Chamber, Hyperbaric
|
510(k) Number |
K962871 |
Device Name |
ODS1 - HOOD DRIVER |
Applicant |
REIMERS SYSTEMS, INC. |
7668 FULLERTON RD., SUITE I-4 |
SPRINGFIELD,
VA
22153
|
|
Applicant Contact |
STEPHEN D REIMERS |
Correspondent |
REIMERS SYSTEMS, INC. |
7668 FULLERTON RD., SUITE I-4 |
SPRINGFIELD,
VA
22153
|
|
Correspondent Contact |
STEPHEN D REIMERS |
Regulation Number | 868.5470
|
Classification Product Code |
|
Date Received | 07/23/1996 |
Decision Date | 10/23/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|