FDA 510(k), K083526, TRILOGY 100 VENTILATOR
FDA 510(k), K083526, TRILOGY 100 VENTILATOR
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510(K) Number: K083526
Device Name: TRILOGY 100 VENTILATOR
Manufacturer: RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
Device Classification Name: ventilator, continuous, facility use
Regulation Number: 868.5895
Classification Product Code: CBK
Date Received: 11/28/2008
Decision Date: 03/13/2009
Regulation Medical Specialty: Anesthesiology
341 pages (6,103 of 6,444 pages are fully redacted)