The following data is part of a premarket notification filed by Hangzhou Hua'an Medical & Health Instruments Co., with the FDA for Jasun, Models Dt-01f And Dt-11f.
| Device ID | K030361 |
| 510k Number | K030361 |
| Device Name: | JASUN, MODELS DT-01F AND DT-11F |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., 4960 TAMARACK DR. Barrington, IL 60010 |
| Contact | Ting Lu |
| Correspondent | Ting Lu HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., 4960 TAMARACK DR. Barrington, IL 60010 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-03 |
| Decision Date | 2003-02-21 |