Device Classification Name |
stethoscope, esophageal, with electrical conductors
|
510(k) Number |
K140134 |
Device Name |
ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE |
Applicant |
STARBOARD MEDICAL, LLC |
22845 Savi Ranch Pkwy Ste H |
Yorba Linda,
CA
92887
|
|
Applicant Contact |
ANTHONY BERAN |
Correspondent |
STARBOARD MEDICAL, LLC |
22845 Savi Ranch Pkwy Ste H |
Yorba Linda,
CA
92887
|
|
Correspondent Contact |
ANTHONY BERAN |
Regulation Number | 868.1920
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/17/2014 |
Decision Date | 06/16/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|