Device Classification Name |
Warmer, Thermal, Infusion Fluid
|
510(k) Number |
K911383 |
Device Name |
HOTLINE FLUID WARMER |
Applicant |
LEVEL 1 TECHNOLOGIES, INC. |
8904 PADDOCK LN. |
POTOMAC,
MD
20854
|
|
Applicant Contact |
BERNARD KONOPKO |
Correspondent |
LEVEL 1 TECHNOLOGIES, INC. |
8904 PADDOCK LN. |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
BERNARD KONOPKO |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/28/1991 |
Decision Date | 10/17/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|