510(k) K132488

ZOLL CODE WRITER by ZOLL Medical Corporation — Product Code DXJ

K132488 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL CODE WRITER". The FDA issued a decision of Substantially Equivalent on April 3, 2014. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2014
Date Received
August 8, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Cathode-Ray Tube, Medical
Device Class
Class II
Regulation Number
870.2450
Review Panel
CV
Submission Type