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FDA 510(k)

CURA 16; ScintCare CT16

K-Number: K173076 · 2018-10-04

ApplicantFmi Medical Systems, Inc.
Decision Date2018-10-04
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CURA 16; ScintCare CT16 is the device name listed in this FDA 510(k) record. The listed applicant is Fmi Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-10-04 under 510(k) number K173076. 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 16; ScintCare CT16?

CURA 16; ScintCare CT16 is a medical device that received FDA 510(k) clearance on 2018-10-04. The listed applicant is Fmi Medical Systems, Inc.. The 510(k) number is K173076.

When did CURA 16; ScintCare CT16 receive FDA 510(k) clearance?

CURA 16; ScintCare CT16 received FDA 510(k) clearance on 2018-10-04, under 510(k) number K173076.

Who is the listed applicant for CURA 16; ScintCare CT16?

The FDA 510(k) record lists Fmi Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CURA 16; ScintCare CT16?

The FDA product code for CURA 16; ScintCare CT16 is JAK.

Other records listing Fmi Medical Systems, Inc. as applicant

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.

K192590CURA 778

Related Devices (Code: JAK)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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