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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 a medical device manufactured by Neosil Co., Ltd.. It received FDA 510(k) clearance on 2018-06-13 under approval 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. It is manufactured by Neosil Co., Ltd.. The 510(k) number is K180565.

When was PEAK NS033CF, PEAK NS017CF approved by the FDA?

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

What company makes PEAK NS033CF, PEAK NS017CF?

PEAK NS033CF, PEAK NS017CF is manufactured by Neosil Co., Ltd..

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

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

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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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