Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K033559
Device Classification Name
Electrode, Electrocardiograph
More FDA Info for this Device
510(K) Number
K033559
Device Name
Electrode, Electrocardiograph
Applicant
INEEDMD
860 CANAL STREET
STAMFORD, CT 06902 US
Other 510(k) Applications for this Company
Contact
IRVING WIESEN, ESQ.
Other 510(k) Applications for this Contact
Regulation Number
870.2360
More FDA Info for this Regulation Number
Classification Product Code
DRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/12/2003
Decision Date
12/22/2004
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