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FDA 510(k)

I RUNE (I-200L)

K-Number: K122410 · 2013-11-12

ApplicantMedirune Co, Ltd.
Decision Date2013-11-12
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

I RUNE (I-200L) is the device name listed in this FDA 510(k) record. The listed applicant is Medirune Co, Ltd.. It received FDA 510(k) clearance on 2013-11-12 under 510(k) number K122410. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I RUNE (I-200L)?

I RUNE (I-200L) is a medical device that received FDA 510(k) clearance on 2013-11-12. The listed applicant is Medirune Co, Ltd.. The 510(k) number is K122410.

When did I RUNE (I-200L) receive FDA 510(k) clearance?

I RUNE (I-200L) received FDA 510(k) clearance on 2013-11-12, under 510(k) number K122410.

Who is the listed applicant for I RUNE (I-200L)?

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

What is the FDA product code for I RUNE (I-200L)?

The FDA product code for I RUNE (I-200L) is NUH.

Related Devices (Code: NUH)

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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