The following data is part of a premarket notification filed by Funai Radio & Communications Corp. with the FDA for Funet Amy Mama Body Thermometer.
| Device ID | K003326 |
| 510k Number | K003326 |
| Device Name: | FUNET AMY MAMA BODY THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | FUNAI RADIO & COMMUNICATIONS CORP. 3F, NO. 24 CHIEN KUO RD. T.E.P.Z. TANTZU Taichung, TW 427 |
| Contact | John Lin |
| Correspondent | John Lin FUNAI RADIO & COMMUNICATIONS CORP. 3F, NO. 24 CHIEN KUO RD. T.E.P.Z. TANTZU Taichung, TW 427 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-24 |
| Decision Date | 2001-04-11 |