Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K955262 |
Device Name |
TRUZONE PEAK FLOW METER |
Applicant |
MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 |
PLATTSBURGH,
NY
12901
|
|
Applicant Contact |
JAMES A COCHIE |
Correspondent |
MONAGHAN MEDICAL CORP. |
5 LATOUR AVE., SUITE 1600 |
PLATTSBURGH,
NY
12901
|
|
Correspondent Contact |
JAMES A COCHIE |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 11/14/1995 |
Decision Date | 03/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|