Device Classification Name |
warmer, thermal, infusion fluid
|
510(k) Number |
K120860 |
Device Name |
INFU BOX TYPE 0412A |
Applicant |
MEDICAL RESCUE EQUIPMENT HOLDING AS |
POSTBOKS 186 |
Porsgrunn,
NO
3901
|
|
Applicant Contact |
KNUT FANGBERGET |
Correspondent |
MEDICAL RESCUE EQUIPMENT HOLDING AS |
POSTBOKS 186 |
Porsgrunn,
NO
3901
|
|
Correspondent Contact |
KNUT FANGBERGET |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/22/2012 |
Decision Date | 05/08/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|