Device Classification Name |
generator, oxygen, portable
|
510(k) Number |
K883591 |
Device Name |
MARK-5 CONCENTRATOR |
Applicant |
NIDEK MEDICAL PRODUCTS, INC. |
2706 S. 19TH ST. |
BIRMINGHAM,
AL
35209
|
|
Applicant Contact |
DON HUNTER |
Correspondent |
NIDEK MEDICAL PRODUCTS, INC. |
2706 S. 19TH ST. |
BIRMINGHAM,
AL
35209
|
|
Correspondent Contact |
DON HUNTER |
Regulation Number | 868.5440
|
Classification Product Code |
|
Date Received | 08/23/1988 |
Decision Date | 11/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|