K080175 is an FDA 510(k) clearance for the NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Datascope Corp., Patient Monitoring Division (Mahwh, US). The FDA issued a Cleared decision on June 9, 2008, 137 days after receiving the submission on January 24, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K080175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 24, 2008 |
| Decision Date | June 09, 2008 |
| Days to Decision | 137 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSZ - Gas-machine, Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5160 |