Device Classification Name |
Spirometer, Monitoring (W/Wo Alarm)
|
510(k) Number |
K884910 |
Device Name |
MODEL 1010, CY-MET |
Applicant |
CYBERMEDIC, INC. |
740 SO PIERCE AVE. |
P.O. BOX 700 |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
LEWIS WARD |
Correspondent |
CYBERMEDIC, INC. |
740 SO PIERCE AVE. |
P.O. BOX 700 |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 868.1850
|
Classification Product Code |
|
Date Received | 11/25/1988 |
Decision Date | 06/12/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|