Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K112114 |
Device Name |
MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 |
Applicant |
MAQUET CRITICAL CARE AB |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Applicant Contact |
WHITNEY TORNING |
Correspondent |
MAQUET CRITICAL CARE AB |
45 BARBOUR POND DRIVE |
WAYNE,
NJ
07470
|
|
Correspondent Contact |
WHITNEY TORNING |
Regulation Number | 868.5160
|
Classification Product Code |
|
Date Received | 07/25/2011 |
Decision Date | 01/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|