K800083 is an FDA 510(k) clearance for the NEBULIZER TUBING SET. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 24, 1980, 10 days after receiving the submission on January 14, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K800083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1980 |
| Decision Date | January 24, 1980 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAF — Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |