Device Classification Name |
Spirometer, Diagnostic
|
510(k) Number |
K133428 |
Device Name |
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO |
Applicant |
MEDIKRO OY |
KELLOLAHDENTIE 27 |
KUOPIO,
FI
FI-70460
|
|
Applicant Contact |
MIKKO ELORANTA |
Correspondent |
MEDIKRO OY |
KELLOLAHDENTIE 27 |
KUOPIO,
FI
FI-70460
|
|
Correspondent Contact |
MIKKO ELORANTA |
Regulation Number | 868.1840
|
Classification Product Code |
|
Date Received | 11/08/2013 |
Decision Date | 05/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|