Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K053156 |
Device Name |
MINI-WRIGHT DIGITAL, MODEL 3120001 |
Applicant |
CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY |
HARLOW, ESSEX,
GB
CM20 2TT
|
|
Applicant Contact |
PHILIP HALLYBONE |
Correspondent |
CLEMENT CLARKE INTL., LTD. |
EDINBURGH WAY |
HARLOW, ESSEX,
GB
CM20 2TT
|
|
Correspondent Contact |
PHILIP HALLYBONE |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 11/14/2005 |
Decision Date | 01/31/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|