510(k) K103473

ZOLL RESCUENET EPCR MODEL RESCUENET EPCR by ZOLL Medical Corporation — Product Code DXJ

K103473 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL RESCUENET EPCR MODEL RESCUENET EPCR". The FDA issued a decision of Substantially Equivalent on May 13, 2011. 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
May 13, 2011
Date Received
November 24, 2010
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