Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K954277 |
Device Name |
ASTECH PEAK FLOW METER |
Applicant |
CENTER LABORATORIES, INC. |
35 CHANNEL DR. |
PORT WASHINGTON,
NY
11050
|
|
Applicant Contact |
RICHARD J MANASSA |
Correspondent |
CENTER LABORATORIES, INC. |
35 CHANNEL DR. |
PORT WASHINGTON,
NY
11050
|
|
Correspondent Contact |
RICHARD J MANASSA |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 09/11/1995 |
Decision Date | 02/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|