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), Dt Series.
Device ID | K092447 |
510k Number | K092447 |
Device Name: | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES |
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 | Ji Bo |
Correspondent | Ji Bo 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-10 |
Decision Date | 2010-01-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00616784561134 | K092447 | 000 |
00616784561035 | K092447 | 000 |