K912906 is an FDA 510(k) clearance for the MEDGRAPHICS PF/DX. This device is classified as a Computer, Oxygen-uptake (Class II - Special Controls, product code BZL).
Submitted by Medical Graphics Corp. (St. Paul, US). The FDA issued a Cleared decision on February 4, 1992, 217 days after receiving the submission on July 2, 1991.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1730.
| 510(k) Number | K912906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1991 |
| Decision Date | February 04, 1992 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZL — Computer, Oxygen-uptake |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1730 |