Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K202197 |
Device Name |
Astopad Patient Warming System |
Applicant |
Stihler Electronic GmbH |
Julius-Hoelder-Strasse 36 |
Stuttgart,
DE
70597
|
|
Applicant Contact |
Jens- Peter Weege |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
Dave Yungvirt |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 08/05/2020 |
Decision Date | 09/04/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|