The following data is part of a premarket notification filed by Neurovision Medical Products, Inc. with the FDA for Signal Gear Urethral Catheter Electrode.
| Device ID | K113771 |
| 510k Number | K113771 |
| Device Name: | SIGNAL GEAR URETHRAL CATHETER ELECTRODE |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 Ventura, CA 93003 |
| Contact | Christine Vergely |
| Correspondent | Christine Vergely NEUROVISION MEDICAL PRODUCTS, INC. 2225 SPERRY AVE SUITE 1000 Ventura, CA 93003 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-22 |
| Decision Date | 2012-12-13 |
| Summary: | summary |