The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Synectics Liberty System, Pc Polygraf And Polygram.
| Device ID | K904625 |
| 510k Number | K904625 |
| Device Name: | SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM |
| Classification | Spirometer, Diagnostic |
| Applicant | SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden, SE S-116 28 |
| Contact | Anna Pettersson |
| Correspondent | Anna Pettersson SYNECTICS-DANTEC RENSTIENAS GATA 12, 5TR. S-116 28 STOCKHOLM Sweden, SE S-116 28 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1991-08-20 |