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FDA 510(k)

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50

K-Number: K230800 · 2023-11-02

ApplicantGEMSS HEALTHCARE CO., LTD.
Decision Date2023-11-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is a medical device manufactured by GEMSS HEALTHCARE CO., LTD.. It received FDA 510(k) clearance on 2023-11-02 under approval number K230800. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is a medical device that received FDA 510(k) clearance on 2023-11-02. It is manufactured by GEMSS HEALTHCARE CO., LTD.. The 510(k) number is K230800.

When was XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 approved by the FDA?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 received FDA 510(k) clearance on 2023-11-02, under approval number K230800.

What company makes XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is manufactured by GEMSS HEALTHCARE CO., LTD..

What is the FDA product code for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50?

The FDA product code for XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 is KPR.

Other Devices by GEMSS HEALTHCARE CO., LTD.

K233200XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

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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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