Submission Details
| 510(k) Number | K962085 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 29, 1996 |
| Decision Date | August 26, 1996 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
SALTER LABS 8990 SERIES NEBULIZER
Aug 1996
Decision
89d
Days
Class 2
Risk
About This 510(k) Submission
K962085 is an FDA 510(k) clearance for the SALTER LABS 8990 SERIES NEBULIZER, 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 August 26, 1996, 89 days after receiving the submission on May 29, 1996. 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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