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FDA 510(k)

LSFG-NAVI

K-Number: K153239 · 2016-05-12

ApplicantSoftcare Co., Ltd.
Decision Date2016-05-12
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LSFG-NAVI is the device name listed in this FDA 510(k) record. The listed applicant is Softcare Co., Ltd.. It received FDA 510(k) clearance on 2016-05-12 under 510(k) number K153239. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LSFG-NAVI?

LSFG-NAVI is a medical device that received FDA 510(k) clearance on 2016-05-12. The listed applicant is Softcare Co., Ltd.. The 510(k) number is K153239.

When did LSFG-NAVI receive FDA 510(k) clearance?

LSFG-NAVI received FDA 510(k) clearance on 2016-05-12, under 510(k) number K153239.

Who is the listed applicant for LSFG-NAVI?

The FDA 510(k) record lists Softcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LSFG-NAVI?

The FDA product code for LSFG-NAVI is HKI.

Related Devices (Code: HKI)

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

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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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