The following data is part of a premarket notification filed by Trp Energy Sensors, Inc. with the FDA for Baby Temp Pacifier.
| Device ID | K822423 |
| 510k Number | K822423 |
| Device Name: | BABY TEMP PACIFIER |
| Classification | Thermometer, Clinical Color Change |
| Applicant | TRP ENERGY SENSORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-12 |
| Decision Date | 1982-10-13 |