Device Classification Name |
Catheter, Electrode Recording, Or Probe, Electrode Recording
|
510(k) Number |
K183632 |
Device Name |
Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable |
Applicant |
Baylis Medical Company Inc. |
2580 Matheson Blvd. E |
Mississauga,
CA
L4W 4J1
|
|
Applicant Contact |
Meghal Khakhar |
Correspondent |
Baylis Medical Company Inc. |
2580 Matheson Blvd. E |
Mississauga,
CA
L4W 4J1
|
|
Correspondent Contact |
Meghal Khakhar |
Regulation Number | 870.1220
|
Classification Product Code |
|
Date Received | 12/26/2018 |
Decision Date | 06/07/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|