Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K980960 |
Device Name |
IN-CHECK INSPIRATORY FLOWMETER |
Applicant |
CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY |
HARLOW,
GB
CM20 2TT
|
|
Applicant Contact |
M J WILKINSON |
Correspondent |
CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY |
HARLOW,
GB
CM20 2TT
|
|
Correspondent Contact |
M J WILKINSON |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 03/16/1998 |
Decision Date | 06/10/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|