K854403 is an FDA 510(k) clearance for the MODEL 2120 SPIROSCREEN. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Gould, Inc. (Dayton, US). The FDA issued a Cleared decision on January 14, 1986, 75 days after receiving the submission on October 31, 1985.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K854403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1985 |
| Decision Date | January 14, 1986 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZG — Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |