Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K000660
Device Classification Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
More FDA Info for this Device
510(K) Number
K000660
Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant
MEDICAL DATA ELECTRONICS
12720 WENTWORTH ST.
ARLETA, CA 91331 US
Other 510(k) Applications for this Company
Contact
Cedric Navarro
Other 510(k) Applications for this Contact
Regulation Number
870.5550
More FDA Info for this Regulation Number
Classification Product Code
DRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2000
Decision Date
03/28/2000
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