K863308 is an FDA 510(k) clearance for the 2200I PHYSIOLOGICAL MONITOR. This device is classified as a Computer, Diagnostic, Pre-programmed, Single-function (Class II - Special Controls, product code DXG).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on January 2, 1987, 130 days after receiving the submission on August 25, 1986.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1435.
| 510(k) Number | K863308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1986 |
| Decision Date | January 02, 1987 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DXG - Computer, Diagnostic, Pre-programmed, Single-function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1435 |