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FDA 510(k)

CURA 778

K-Number: K192590 · 2020-03-05

ApplicantFmi Medical Systems, Inc.
Decision Date2020-03-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CURA 778 is a medical device manufactured by Fmi Medical Systems, Inc.. It received FDA 510(k) clearance on 2020-03-05 under approval number K192590. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CURA 778?

CURA 778 is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by Fmi Medical Systems, Inc.. The 510(k) number is K192590.

When was CURA 778 approved by the FDA?

CURA 778 received FDA 510(k) clearance on 2020-03-05, under approval number K192590.

What company makes CURA 778?

CURA 778 is manufactured by Fmi Medical Systems, Inc..

What is the FDA product code for CURA 778?

The FDA product code for CURA 778 is JAK.

Other Devices by Fmi Medical Systems, Inc.

K173076CURA 16; ScintCare CT16

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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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