Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K113705 |
Device Name |
PINTLER PATIENT WARMING SYSTEM |
Applicant |
PINTLER MEDICAL |
3220 S. HANFORD STREET |
SEATTLE,
WA
98144
|
|
Applicant Contact |
Kent Ellis |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
PAULA WILKERSON |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 12/16/2011 |
Decision Date | 08/31/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|