The following data is part of a premarket notification filed by Life-tech Instruments, Inc. with the FDA for Catheter, Urethral Pressure, Upe-10 & 12.
| Device ID | K770579 |
| 510k Number | K770579 |
| Device Name: | CATHETER, URETHRAL PRESSURE, UPE-10 & 12 |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | LIFE-TECH INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-28 |
| Decision Date | 1977-05-23 |