K904625 is an FDA 510(k) clearance for the SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on August 20, 1991, 314 days after receiving the submission on October 10, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K904625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1990 |
| Decision Date | August 20, 1991 |
| Days to Decision | 314 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 |