Device Classification Name |
Pulse-Generator, Pacemaker, External
|
510(k) Number |
K123916 |
Device Name |
PSA SERIES |
Applicant |
OSYPKA MEDICAL, INC. |
7855 IVANHOE AVE., SUITE 226 |
LA JOLLA,
CA
92037
|
|
Applicant Contact |
MARKUS OSYPKA |
Correspondent |
OSYPKA MEDICAL, INC. |
7855 IVANHOE AVE., SUITE 226 |
LA JOLLA,
CA
92037
|
|
Correspondent Contact |
MARKUS OSYPKA |
Regulation Number | 870.3600
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/19/2012 |
Decision Date | 04/09/2013 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|