Device Classification Name |
pneumotachometer
|
510(k) Number |
K884464 |
Device Name |
SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR |
Applicant |
SPIROMETRICS, INC. |
33 OMNI CIRCLE |
AUBURN,
ME
04210 -1210
|
|
Applicant Contact |
ALLEN G CYR |
Correspondent |
SPIROMETRICS, INC. |
33 OMNI CIRCLE |
AUBURN,
ME
04210 -1210
|
|
Correspondent Contact |
ALLEN G CYR |
Regulation Number | 868.2550
|
Classification Product Code |
|
Date Received | 10/24/1988 |
Decision Date | 01/19/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|