Device Classification Name |
spirometer, diagnostic
|
510(k) Number |
K031102 |
Device Name |
MICROLAB SPIROMETER |
Applicant |
MICRO DIRECT, INC. |
803 WEBSTER ST. |
LEWISTON,
ME
04240
|
|
Applicant Contact |
DAVID R STASZAK |
Correspondent |
MICRO DIRECT, INC. |
803 WEBSTER ST. |
LEWISTON,
ME
04240
|
|
Correspondent Contact |
DAVID R STASZAK |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 04/07/2003 |
Decision Date | 12/01/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|