K984031 is an FDA 510(k) clearance for the SPIROVIT, MODEL SP-250. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on April 30, 1999, 169 days after receiving the submission on November 12, 1998.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K984031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1998 |
| Decision Date | April 30, 1999 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG - Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |