The following data is part of a premarket notification filed by Hangzhou Hua'an Medical & Health Instruments Co., with the FDA for Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier Thermometer.
| Device ID | K041694 |
| 510k Number | K041694 |
| Device Name: | DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BUILDING 2, BAIMIAO INDU. PARK ECONOMIC DEVELOP. ZONE WUCHANG Hangzhou, Zhejiang, CN 310023 |
| Contact | Ji Bo |
| Correspondent | Ji Bo HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BUILDING 2, BAIMIAO INDU. PARK ECONOMIC DEVELOP. ZONE WUCHANG Hangzhou, Zhejiang, CN 310023 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-22 |
| Decision Date | 2004-09-13 |