Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K033513
Device Classification Name
Adaptor, Lead Switching, Electrocardiograph
More FDA Info for this Device
510(K) Number
K033513
Device Name
Adaptor, Lead Switching, Electrocardiograph
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
Other 510(k) Applications for this Company
Contact
DAVID OSBORN
Other 510(k) Applications for this Contact
Regulation Number
870.2350
More FDA Info for this Regulation Number
Classification Product Code
DRW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/06/2003
Decision Date
01/15/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact