Submission Details
| 510(k) Number | K961476 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 18, 1996 |
| Decision Date | July 16, 1996 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
Jul 1996
Decision
89d
Days
Class 2
Risk
About This 510(k) Submission
K961476 is an FDA 510(k) clearance for the SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984), 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 July 16, 1996, 89 days after receiving the submission on April 18, 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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