SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER

About This 510(k) Submission

K992986 is an FDA 510(k) clearance for the SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on September 24, 1999, 21 days after receiving the submission on September 3, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.