FDA 510(k), K223073, Alio

510(K) Number: K223073
Device Name: Alio
Manufacturer: Kimberly Snyder
Device Classification Name: Transmitters And Receivers, Physiological Signal, Radiofrequency
Classification Product Code: DRG
Date Received: 09/30/2022
Decision Date: 03/17/2023
Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

Contents: Indications for Use; 510k Summary; eSTAR; Substantial Equivalence Letter; Overview of Predicate Devices; Acknowledgement Letter; Certification of Compliance; Traditional 51 0(k) Premarket Notification; Labeling; Summary of Testing; Certification: Financial Interests and Arrangements of Clinical Investigators