K961661 is an FDA 510(k) clearance for the OXIMETRIX 4 COMPUTER SYSTEM. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 4, 1997, 308 days after receiving the submission on April 30, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K961661 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1996 |
| Decision Date | March 04, 1997 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXG — Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |