Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993205
Device Classification Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
More FDA Info for this Device
510(K) Number
K993205
Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Applicant
TZ MEDICAL, INC.
15858 S.W. UPPER BOONES FERRY
RD.
LAKE OSWEGO, OR 97035 US
Other 510(k) Applications for this Company
Contact
BYRON KAHLER
Other 510(k) Applications for this Contact
Regulation Number
870.5300
More FDA Info for this Regulation Number
Classification Product Code
LDD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/1999
Decision Date
07/20/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact