THE IMS DPAP MASK, IMS MODEL NUMBER 82000

About This 510(k) Submission

K953697 is an FDA 510(k) clearance for the THE IMS DPAP MASK, IMS MODEL NUMBER 82000, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Sleepnet Corporation (Manchester, US). The FDA issued a Cleared decision on June 13, 1996, 310 days after receiving the submission on August 8, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.