K760448 is an FDA 510(k) clearance for the SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT. This device is classified as a Injector, Indicator (Class II - Special Controls, product code DXL).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on August 27, 1976, 11 days after receiving the submission on August 16, 1976.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1660.
| 510(k) Number | K760448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 1976 |
| Decision Date | August 27, 1976 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DXL — Injector, Indicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1660 |