The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Actherm Digital Clinical Thermometer Probe Covers, Model(s) Medaccu1010, Medaccu1010-1, Medaccu1020.
| Device ID | K083419 |
| 510k Number | K083419 |
| Device Name: | ACTHERM DIGITAL CLINICAL THERMOMETER PROBE COVERS, MODEL(S) MEDACCU1010, MEDACCU1010-1, MEDACCU1020 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ACTHERM, INC. 6F, NO.18 JHANYE 2ND RD., HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Richard Hsieh |
| Correspondent | Richard Hsieh ACTHERM, INC. 6F, NO.18 JHANYE 2ND RD., HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-07-16 |
| Summary: | summary |