The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for F.m. Weist,kg (urodynamic Systems).
| Device ID | K860571 |
| 510k Number | K860571 |
| Device Name: | F.M. WEIST,KG (URODYNAMIC SYSTEMS) |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
| Contact | Wayne W Disanza |
| Correspondent | Wayne W Disanza F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-03-18 |