Submission Details
| 510(k) Number | K911740 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 17, 1991 |
| Decision Date | July 24, 1991 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
Cleared
Traditional
SALTER LABS NEONATAL NASAL OXYGEN CANNULA
Jul 1991
Decision
98d
Days
Class 1
Risk
About This 510(k) Submission
K911740 is an FDA 510(k) clearance for the SALTER LABS NEONATAL NASAL OXYGEN CANNULA, a Cannula, Nasal, Oxygen (Class I — General Controls, product code CAT), submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 24, 1991, 98 days after receiving the submission on April 17, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5340.
Device Classification
| Product Code | CAT — Cannula, Nasal, Oxygen |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.5340 |
Manufacturer
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