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 |