K080039 is an FDA 510(k) clearance for the PASSIVE WASTE GAS SCAVENGER, MODEL 14600. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).
Submitted by G. Dundas Co.,Inc. (Black Diamond, US). The FDA issued a Cleared decision on April 14, 2008, 98 days after receiving the submission on January 7, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.
| 510(k) Number | K080039 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 07, 2008 |
| Decision Date | April 14, 2008 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBN — Apparatus, Gas-scavenging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5430 |