FDA 510(k), K113514, SMARTHEART

FDA 510(k), K113514, SMARTHEART

Regular price $149.00 USD
Regular price Sale price $149.00 USD
Sale Sold out
510(K) Number: K113514
Device Name: SMARTHEART
Manufacturer: SHL TELEMEDICINE INTERNATIONAL LTD.
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 11/28/2011
Decision Date: 02/22/2012
Regulation Medical Specialty: Cardiovascular

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

View full details