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FDA 510(k)

PrisMax System Version 3

K-Number: K193482 · 2020-03-13

ApplicantBaxter Healthcare Corporation
Decision Date2020-03-13
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PrisMax System Version 3 is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2020-03-13 under approval number K193482. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrisMax System Version 3?

PrisMax System Version 3 is a medical device that received FDA 510(k) clearance on 2020-03-13. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K193482.

When was PrisMax System Version 3 approved by the FDA?

PrisMax System Version 3 received FDA 510(k) clearance on 2020-03-13, under approval number K193482.

What company makes PrisMax System Version 3?

PrisMax System Version 3 is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for PrisMax System Version 3?

The FDA product code for PrisMax System Version 3 is KDI.

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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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