Device Classification Name |
spirometer, therapeutic (incentive)
|
510(k) Number |
K080299 |
Device Name |
RESPIFIT S, MODEL RS-LR1001004 |
Applicant |
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH |
1341 W FULLERTON |
SUITE 103 |
CHICAGO,
IL
60014
|
|
Applicant Contact |
DAVID LEVINE |
Correspondent |
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH |
1341 W FULLERTON |
SUITE 103 |
CHICAGO,
IL
60014
|
|
Correspondent Contact |
DAVID LEVINE |
Regulation Number | 868.5690
|
Classification Product Code |
|
Date Received | 02/05/2008 |
Decision Date | 01/13/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|