Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K101380 |
Device Name |
RXPEAKFLOW |
Applicant |
NOBLE MARKETING |
11460 N. MERIDIAN ST. |
SUITE 150 |
CARMEL,
IN
46032
|
|
Applicant Contact |
LAURA LYONS |
Correspondent |
NOBLE MARKETING |
11460 N. MERIDIAN ST. |
SUITE 150 |
CARMEL,
IN
46032
|
|
Correspondent Contact |
LAURA LYONS |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 05/17/2010 |
Decision Date | 09/13/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|