The following data is part of a premarket notification filed by Hangzhou Hua'an Medical & Health Instruments Co., with the FDA for Digital Thermometer (with Disposable Thermometer Cover).
| Device ID | K122912 |
| 510k Number | K122912 |
| Device Name: | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE Wuchang, Hangzhou, Zhejiang, CN 310023 |
| Contact | Ahneo Yang |
| Correspondent | Ahneo Yang HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., BLDG 2, BAIMIAO IND. PARK ECONOMIC DEVELOPMENT ZONE Wuchang, Hangzhou, Zhejiang, CN 310023 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-21 |
| Decision Date | 2012-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810038630189 | K122912 | 000 |
| 10850003180035 | K122912 | 000 |
| 10810038631605 | K122912 | 000 |