Device Classification Name |
Stethoscope, Esophageal, With Electrical Conductors
|
510(k) Number |
K062020 |
Device Name |
LIFESOUND ESOPHAGEAL STETHOSCOPE |
Applicant |
NOVAMED, LLC |
3460 POINTE CREEK CT. #102 |
BONITA SPRINGS,
FL
34134 -2015
|
|
Applicant Contact |
PAUL DRYDEN |
Correspondent |
NOVAMED, LLC |
3460 POINTE CREEK CT. #102 |
BONITA SPRINGS,
FL
34134 -2015
|
|
Correspondent Contact |
PAUL DRYDEN |
Regulation Number | 868.1920
|
Classification Product Code |
|
Date Received | 07/17/2006 |
Decision Date | 09/05/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|