Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K031514 |
Device Name |
MODIFICATION TO TRUPEAK PEAK FLOW METER |
Applicant |
MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 |
P.O. BOX 2805 |
PLATTSBURGH,
NY
12901
|
|
Applicant Contact |
JAMES A COCHIE |
Correspondent |
MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 |
P.O. BOX 2805 |
PLATTSBURGH,
NY
12901
|
|
Correspondent Contact |
JAMES A COCHIE |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 05/14/2003 |
Decision Date | 05/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|