Device Classification Name |
Warmer, Thermal, Infusion Fluid
|
510(k) Number |
K130867 |
Device Name |
ENFLOW IV FLUID WARMER INSULATED STRAP |
Applicant |
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
20 CAMPUS RD |
TOTOWA,
NJ
07512
|
|
Applicant Contact |
STACIE GEFFNER-ATIYA |
Correspondent |
VITAL SIGNS, INC., A GE HEALTHCARE COMPANY |
20 CAMPUS RD |
TOTOWA,
NJ
07512
|
|
Correspondent Contact |
STACIE GEFFNER-ATIYA |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/28/2013 |
Decision Date | 06/14/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|