The following data is part of a premarket notification filed by Synectics Medical, Inc. with the FDA for Urodynamic Analysis Module.
| Device ID | K963330 |
| 510k Number | K963330 |
| Device Name: | URODYNAMIC ANALYSIS MODULE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | SYNECTICS MEDICAL, INC. RENSTIENAS GATA 12, 5TR. S-116 28 Stockholm, SE S-11628 |
| Contact | Anna Petterson |
| Correspondent | Anna Petterson SYNECTICS MEDICAL, INC. RENSTIENAS GATA 12, 5TR. S-116 28 Stockholm, SE S-11628 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-23 |
| Decision Date | 1997-04-03 |
| Summary: | summary |