FDA 510(k), K213794, Eko Murmur Analysis Software (EMAS)

510(K) Number: K213794
Device Name: Eko Murmur Analysis Software (EMAS)
Manufacturer: Sam Huang
Device Classification Name: Stethoscope, Electronic
Regulation Number: DQD
Classification Product Code: KXA
Date Received: 12/06/2021
Decision Date: 06/29/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular

Total Pages: 858
Fully Redacted Pages: 660
Content Pages: 198