Device Classification Name |
system, thermal regulating
|
510(k) Number |
K162562 |
Device Name |
OPT-SHIELD AIR, SUPINE; OPT-SHIELD, LITHOTOMY |
Applicant |
BCG MEDICAL, LLC |
6715 RANCHO TOYON PLACE |
SAN DIEGO,
CA
92130
|
|
Applicant Contact |
LISA GIAP |
Correspondent |
BCG MEDICAL, LLC |
6715 RANCHO TOYON PLACE |
SAN DIEGO,
CA
92130
|
|
Correspondent Contact |
LISA GIAP |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 09/14/2016 |
Decision Date | 03/17/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|