Device Classification Name |
warmer, thermal, infusion fluid
|
510(k) Number |
K102900 |
Device Name |
HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM |
Applicant |
HEI, INC. |
4801 NORTH 63RD. ST. |
BOULDER,
CO
80301
|
|
Applicant Contact |
GREGORY MATHISON |
Correspondent |
HEI, INC. |
4801 NORTH 63RD. ST. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
GREGORY MATHISON |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 09/30/2010 |
Decision Date | 03/21/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|