Power Infuser

FDA 510(k) K172653 · ZOLL Medical Corporation

Substantially Equivalent

510(k) numberK172653

Submission

Device name
Power Infuser
Applicant
ZOLL Medical Corporation
Chelsmford, MA, US
Received
September 5, 2017
Decision date
July 18, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FRN – Pump, Infusion
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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Questions and answers

When was Power Infuser cleared by the FDA?

Power Infuser (K172653) received a 510(k) decision of Substantially Equivalent on July 18, 2018, 316 days after the submission was received.

What is the product code of K172653?

The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.