Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K972371 |
Device Name |
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR |
Applicant |
BRASAMERICA MEDICAL EQUIPMENT, INC. |
55 NORTHERN BLVD., SUITE 410 |
GREAT NECK,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
BRASAMERICA MEDICAL EQUIPMENT, INC. |
55 NORTHERN BLVD., SUITE 410 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/25/1997 |
Decision Date | 08/19/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|