Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K942384 |
Device Name |
ENDURANCE R3000 |
Applicant |
ESSENTIAL MEDICAL SUPPLY, INC. |
6937-A STAPOINT COURT |
WINTER PARK,
FL
32792
|
|
Applicant Contact |
CAROL A HOEPNER |
Correspondent |
ESSENTIAL MEDICAL SUPPLY, INC. |
6937-A STAPOINT COURT |
WINTER PARK,
FL
32792
|
|
Correspondent Contact |
CAROL A HOEPNER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/19/1994 |
Decision Date | 12/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|