Device Classification Name |
percussor, powered-electric
|
510(k) Number |
K060439 |
Device Name |
LUNG FLUTE |
Applicant |
MEDICAL ACOUSTICS LLC |
255 GREAT ARROW AVE., |
SUITE 23 |
BUFFALO,
NY
14207
|
|
Applicant Contact |
NICOLAAS J SMIT |
Correspondent |
MEDICAL ACOUSTICS LLC |
255 GREAT ARROW AVE., |
SUITE 23 |
BUFFALO,
NY
14207
|
|
Correspondent Contact |
NICOLAAS J SMIT |
Regulation Number | 868.5665
|
Classification Product Code |
|
Date Received | 02/21/2006 |
Decision Date | 06/22/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|