Rune Labs Tremor Transducer System

Transducer, Tremor

Rune Labs, Inc.

The following data is part of a premarket notification filed by Rune Labs, Inc. with the FDA for Rune Labs Tremor Transducer System.

Pre-market Notification Details

Device IDK213519
510k NumberK213519
Device Name:Rune Labs Tremor Transducer System
ClassificationTransducer, Tremor
Applicant Rune Labs, Inc. 649 Iriving Street San Francisco,  CA  94122
ContactBrian Pepin
CorrespondentCourtney Lane
Anacapa Clinical Research Inc. 2421 Sunset Dr. Ventura,  CA  93001
Product CodeGYD  
Subsequent Product CodeISD
Subsequent Product CodeNXQ
CFR Regulation Number882.1950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-03
Decision Date2022-06-10

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