Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K983736 |
Device Name |
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER |
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 | 10/22/1998 |
Decision Date | 11/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|