The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Modified Foley Catheter/temperature Sensor.
| Device ID | K874525 |
| 510k Number | K874525 |
| Device Name: | MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR |
| Classification | Catheter, Urological |
| Applicant | MON-A-THERM, INC. ST. LOUIS BUSINESS CENTER 500 SOUTH EWING AVENUE St. Louis, MO 63103 |
| Contact | Alan T Beckman |
| Correspondent | Alan T Beckman MON-A-THERM, INC. ST. LOUIS BUSINESS CENTER 500 SOUTH EWING AVENUE St. Louis, MO 63103 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1988-01-06 |