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 a medical device manufactured by Rune Labs, Inc.. It received FDA 510(k) clearance on 2022-06-10 under approval 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. It is manufactured by Rune Labs, Inc.. The 510(k) number is K213519.
When was Rune Labs Tremor Transducer System approved by the FDA?
Rune Labs Tremor Transducer System received FDA 510(k) clearance on 2022-06-10, under approval number K213519.
What company makes Rune Labs Tremor Transducer System?
Rune Labs Tremor Transducer System is manufactured by Rune Labs, Inc..
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.