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FDA 510(k)

Single Use Injector NM600/610

K-Number: K153625 · 2016-02-12

ApplicantOlympus Medical Systems Corp.
Decision Date2016-02-12
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single Use Injector NM600/610 is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2016-02-12 under approval number K153625. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Single Use Injector NM600/610?

Single Use Injector NM600/610 is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K153625.

When was Single Use Injector NM600/610 approved by the FDA?

Single Use Injector NM600/610 received FDA 510(k) clearance on 2016-02-12, under approval number K153625.

What company makes Single Use Injector NM600/610?

Single Use Injector NM600/610 is manufactured by Olympus Medical Systems Corp..

What is the FDA product code for Single Use Injector NM600/610?

The FDA product code for Single Use Injector NM600/610 is FBK.

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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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