Device Classification Name |
calculator, pulmonary function data
|
510(k) Number |
K861418 |
Device Name |
SPINNAKER |
Applicant |
CYBERMEDIC, INC. |
P.O. BOX 3468 |
BOULDER,
CO
80307
|
|
Applicant Contact |
CURT BROWN |
Correspondent |
CYBERMEDIC, INC. |
P.O. BOX 3468 |
BOULDER,
CO
80307
|
|
Correspondent Contact |
CURT BROWN |
Regulation Number | 868.1880
|
Classification Product Code |
|
Date Received | 04/15/1986 |
Decision Date | 05/09/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|