K921309 is an FDA 510(k) clearance for the MODEL 508 PATIENT MONITOR. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Criticare Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 17, 1993, 647 days after receiving the submission on March 10, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K921309 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1992 |
| Decision Date | December 17, 1993 |
| Days to Decision | 647 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTY — Calculator, Predicted Values, Pulmonary Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |