Device Classification Name |
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
|
510(k) Number |
K121722 |
Device Name |
ESA620 ELECTRICAL SAFETY ANALYZER |
Applicant |
FLUKE BIOMEDICAL |
6045 COCHRAN RD. |
SOLON,
OH
44139
|
|
Applicant Contact |
JOHN NELSON |
Correspondent |
FLUKE BIOMEDICAL |
6045 COCHRAN RD. |
SOLON,
OH
44139
|
|
Correspondent Contact |
JOHN NELSON |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 06/12/2012 |
Decision Date | 10/11/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|