The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Digital Clinical Thermometer, Model Act 3020.
| Device ID | K021614 |
| 510k Number | K021614 |
| Device Name: | DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACTHERM, INC. 6TH F, NO 85 KUAN-MIN 6 ROAD JUBEI 302 Hsinchu, TW 302 |
| Contact | Richard Hsieh |
| Correspondent | Richard Hsieh ACTHERM, INC. 6TH F, NO 85 KUAN-MIN 6 ROAD JUBEI 302 Hsinchu, TW 302 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-05-30 |