Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K880473 |
Device Name |
AERO-MIST NEBULIZER HEATER |
Applicant |
PEGASUS RESEARCH CORP. |
3334 E. COAST HIGHWAY, SUITE |
297 |
CORONA DEL MAR,
CA
92625
|
|
Applicant Contact |
KENNETH G MILLER |
Correspondent |
PEGASUS RESEARCH CORP. |
3334 E. COAST HIGHWAY, SUITE |
297 |
CORONA DEL MAR,
CA
92625
|
|
Correspondent Contact |
KENNETH G MILLER |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/04/1988 |
Decision Date | 03/31/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|