FDA 510(k), K161487, VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

510(K) Number: K161487
Device Name: VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
Manufacturer: ResMed Ltd
Device Classification Name: Ventilator, Continuous, Non-Life-Supporting
Regulation Number: 868.5895
Classification Product Code: MNS
Date Received: 05/31/2016
Decision Date: 09/09/2016
Regulation Medical Specialty: Anesthesiology

800 pages (261 of 1061 original pages are fully redacted)