Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K982956 |
Device Name |
FLOWMATE II PLUS, MODEL #4000 |
Applicant |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
415 RODMAN RD. |
AUBURN,
ME
04210
|
|
Applicant Contact |
DONALD HENTON |
Correspondent |
SPIROMETRICS MEDICAL EQUIPMENT CO. |
415 RODMAN RD. |
AUBURN,
ME
04210
|
|
Correspondent Contact |
DONALD HENTON |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 08/24/1998 |
Decision Date | 11/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|