Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K031982 |
Device Name |
BIRDSONG LEVERHALER, MODEL LH-1000 |
Applicant |
BIRDSONG MEDICAL DEVICES INC |
1456 RT 22 |
BREWSTER,
NY
10509
|
|
Applicant Contact |
ERIC FUGELSANG |
Correspondent |
BIRDSONG MEDICAL DEVICES INC |
1456 RT 22 |
BREWSTER,
NY
10509
|
|
Correspondent Contact |
ERIC FUGELSANG |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 06/26/2003 |
Decision Date | 04/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|