The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Mon-a-therm's Skin Temperature Sensor.
| Device ID | K875234 |
| 510k Number | K875234 |
| Device Name: | MON-A-THERM'S SKIN TEMPERATURE SENSOR |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | MON-A-THERM, INC. ST. LOUIS BUSINESS CENTER 500 SOUTH EWING AVENUE St. Louis, MO 63103 |
| Contact | Alan Beckman |
| Correspondent | Alan Beckman MON-A-THERM, INC. ST. LOUIS BUSINESS CENTER 500 SOUTH EWING AVENUE St. Louis, MO 63103 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-01-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521031576 | K875234 | 000 |
| 20884521817545 | K875234 | 000 |