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FDA 510(k)

ProntoPump Sterile Tube Set

K-Number: K200893 · 2021-05-04

ApplicantIpax, Inc.
Decision Date2021-05-04
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ProntoPump Sterile Tube Set is a medical device manufactured by Ipax, Inc.. It received FDA 510(k) clearance on 2021-05-04 under approval number K200893. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProntoPump Sterile Tube Set?

ProntoPump Sterile Tube Set is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Ipax, Inc.. The 510(k) number is K200893.

When was ProntoPump Sterile Tube Set approved by the FDA?

ProntoPump Sterile Tube Set received FDA 510(k) clearance on 2021-05-04, under approval number K200893.

What company makes ProntoPump Sterile Tube Set?

ProntoPump Sterile Tube Set is manufactured by Ipax, Inc..

What is the FDA product code for ProntoPump Sterile Tube Set?

The FDA product code for ProntoPump Sterile Tube Set is LHI.

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Official Source

View on FDA Database →

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

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