Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K033130
Device Classification Name
Pulse-Generator, Pacemaker, External
More FDA Info for this Device
510(K) Number
K033130
Device Name
Pulse-Generator, Pacemaker, External
Applicant
OSYPKA MEDICAL, INC.
7855 IVANHOE AVE.
SUITE 226
LA JOLLA, CA 92037 US
Other 510(k) Applications for this Company
Contact
MARKUS J OSYPKA
Other 510(k) Applications for this Contact
Regulation Number
870.3600
More FDA Info for this Regulation Number
Classification Product Code
DTE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/30/2003
Decision Date
10/31/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact