The following data is part of a premarket notification filed by Questech Intl., Inc. with the FDA for Pacifier-thermometer.
| Device ID | K943362 |
| 510k Number | K943362 |
| Device Name: | PACIFIER-THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | QUESTECH INTL., INC. 4951-B EAST ADAMO DR., SUITE 238 Tampa, FL 33605 |
| Contact | Patrick Lamb |
| Correspondent | Patrick Lamb QUESTECH INTL., INC. 4951-B EAST ADAMO DR., SUITE 238 Tampa, FL 33605 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-13 |
| Decision Date | 1995-02-21 |