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 |