510(k) K090736

POWER INFUSER, MODEL M100B-3A by ZOLL Medical Corporation — Product Code FRN

K090736 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "POWER INFUSER, MODEL M100B-3A". The FDA issued a decision of Substantially Equivalent on May 20, 2009. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2009
Date Received
March 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type