FDA 510(k), K221614, TytoCare Lung Sounds Analyzer

510(K) Number: K221614
Device Name: TytoCare Lung Sounds Analyzer
Manufacturer: Stella Raizelman Perry
Device Classification Name: Abnormal Breath Sound Device
Regulation Number: PHZ
Classification Product Code: KXA
Date Received: 06/03/2022
Decision Date: 02/24/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology

542 pages (1,165 of 1,707 were fully redacted)