Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
510(k) Number |
K884465 |
Device Name |
SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) |
Applicant |
SPIROMETRICS, INC. |
33 OMNI CIRCLE |
AUBURN,
ME
04210 -1210
|
|
Applicant Contact |
G CYR |
Correspondent |
SPIROMETRICS, INC. |
33 OMNI CIRCLE |
AUBURN,
ME
04210 -1210
|
|
Correspondent Contact |
G CYR |
Regulation Number | 868.5260 |
Classification Product Code |
|
Date Received | 10/24/1988 |
Decision Date | 11/09/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|