The following data is part of a premarket notification filed by Mon-a-therm, Inc. with the FDA for Model 1000 Electronic Clinical Thermometer.
| Device ID | K885187 |
| 510k Number | K885187 |
| Device Name: | MODEL 1000 ELECTRONIC CLINICAL THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| 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 | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-03-08 |