FDA 510(k), K140054, RESCAN

510(K) Number: K140054
Device Name: RESCAN
Manufacturer: RESMED LTD
Device Classification Name: Ventilator, Non-Continuous (Respirator)
Regulation Number: 868.5905
Classification Product Code: BZD
Date Received: 01/09/2014
Decision Date: 05/16/2014
Regulation Medical Specialty: Anesthesiology

245 pages (595 of 840 original pages are fully redacted)