FDA 510(k), K190548, BIOMONITOR III, Remote Assistant III

510(K) Number: K190548
Device Name: BIOMONITOR III, Remote Assistant III
Manufacturer: Biotronik, Inc.
Device Classification Name: recorder, event, implantable cardiac, (with arrhythmia detection)
Regulation Number: 870.1025
Classification Product Code: MXD
Date Received: 03/05/2019
Decision Date: 07/05/2019
Regulation Medical Specialty: Cardiovascular

842 pages (10,553 of 11,395 original pages are fully redacted)