Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K950223 |
Device Name |
DISCOVERY GRAPHIC PORTABLE SPIROMETER |
Applicant |
FUTUREMED AMERICA, INC. |
2076 DEER PARK AVE. |
DEER PARK,
NY
11729
|
|
Applicant Contact |
MICHAEL DAVIDSON |
Correspondent |
FUTUREMED AMERICA, INC. |
2076 DEER PARK AVE. |
DEER PARK,
NY
11729
|
|
Correspondent Contact |
MICHAEL DAVIDSON |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 01/10/1995 |
Decision Date | 11/17/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|