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 |