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FDA 510(k)

PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101

K-Number: K023548 · 2003-08-04

ApplicantVelocimed
Decision Date2003-08-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 is the device name listed in this FDA 510(k) record. The listed applicant is Velocimed. It received FDA 510(k) clearance on 2003-08-04 under 510(k) number K023548. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101?

PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 is a medical device that received FDA 510(k) clearance on 2003-08-04. The listed applicant is Velocimed. The 510(k) number is K023548.

When did PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 receive FDA 510(k) clearance?

PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 received FDA 510(k) clearance on 2003-08-04, under 510(k) number K023548.

Who is the listed applicant for PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101?

The FDA 510(k) record lists Velocimed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101?

The FDA product code for PROXIS FLOW-CONTROL DEVICE, MODELS EPS 101, IC 101 is DQY.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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