Submission Details
| 510(k) Number | K983403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 27, 1998 |
| Decision Date | December 17, 1998 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
Dec 1998
Decision
81d
Days
Class 2
Risk
About This 510(k) Submission
K983403 is an FDA 510(k) clearance for the SALTER LABS NEBULIZER 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 December 17, 1998, 81 days after receiving the submission on September 27, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.
Device Classification
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5630 |
Manufacturer
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