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FDA 510(k)

PEAK NS033CF, PEAK NS017CF

K-Number: K180565 · 2018-06-13

ApplicantNeosil Co., Ltd.
Decision Date2018-06-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PEAK NS033CF, PEAK NS017CF is the device name listed in this FDA 510(k) record. The listed applicant is Neosil Co., Ltd.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K180565. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEAK NS033CF, PEAK NS017CF?

PEAK NS033CF, PEAK NS017CF is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Neosil Co., Ltd.. The 510(k) number is K180565.

When did PEAK NS033CF, PEAK NS017CF receive FDA 510(k) clearance?

PEAK NS033CF, PEAK NS017CF received FDA 510(k) clearance on 2018-06-13, under 510(k) number K180565.

Who is the listed applicant for PEAK NS033CF, PEAK NS017CF?

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

What is the FDA product code for PEAK NS033CF, PEAK NS017CF?

The FDA product code for PEAK NS033CF, PEAK NS017CF is ELW.

Related Devices (Code: ELW)

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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