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 |