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FDA 510(k)

PrismaSATE

K-Number: K162887 · 2017-01-06

ApplicantBaxter Healthcare Corporation
Decision Date2017-01-06
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PrismaSATE 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 2017-01-06 under 510(k) number K162887. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PrismaSATE?

PrismaSATE is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K162887.

When did PrismaSATE receive FDA 510(k) clearance?

PrismaSATE received FDA 510(k) clearance on 2017-01-06, under 510(k) number K162887.

Who is the listed applicant for PrismaSATE?

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 PrismaSATE?

The FDA product code for PrismaSATE is KPO.

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Related Devices (Code: KPO)

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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