K980094 is an FDA 510(k) clearance for the MODIFICATION TO THE OXYCONALPHA. This device is classified as a Calculator, Predicted Values, Pulmonary Function (Class II - Special Controls, product code BTY).
Submitted by Erich Jaeger B.V. (Nl-3981 La Bunnik, NL). The FDA issued a Cleared decision on July 28, 1998, 200 days after receiving the submission on January 9, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K980094 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1998 |
| Decision Date | July 28, 1998 |
| Days to Decision | 200 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 |