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FDA 510(k)

Rune Labs Tremor Transducer System

K-Number: K213519 · 2022-06-10

ApplicantRune Labs, Inc.
Decision Date2022-06-10
Product CodeGYD
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Rune Labs Tremor Transducer System is the device name listed in this FDA 510(k) record. The listed applicant is Rune Labs, Inc.. It received FDA 510(k) clearance on 2022-06-10 under 510(k) number K213519. The device is classified under product code GYD. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rune Labs Tremor Transducer System?

Rune Labs Tremor Transducer System is a medical device that received FDA 510(k) clearance on 2022-06-10. The listed applicant is Rune Labs, Inc.. The 510(k) number is K213519.

When did Rune Labs Tremor Transducer System receive FDA 510(k) clearance?

Rune Labs Tremor Transducer System received FDA 510(k) clearance on 2022-06-10, under 510(k) number K213519.

Who is the listed applicant for Rune Labs Tremor Transducer System?

The FDA 510(k) record lists Rune Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rune Labs Tremor Transducer System?

The FDA product code for Rune Labs Tremor Transducer System is GYD.

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Official Source

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