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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 the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2020-03-13 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K193482.

When did PrisMax System Version 3 receive FDA 510(k) clearance?

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

Who is the listed applicant for PrisMax System Version 3?

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

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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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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