Hangzhou Hua'an Medical & Health Instruments Co.
Hangzhou Zhejiang, CN
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Hangzhou Hua'an Medical & Health Instruments Co. between 2003 and 2018. The busiest year on record is 2004, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172870 | Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J | FLL | Substantially Equivalent | |
| K172861 | Digital thermometer(with disposable thermometer cover) | FLL | Substantially Equivalent | |
| K160999 | Infra-red forehead thermometer | FLL | Substantially Equivalent | |
| K122912 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER) | FLL | Substantially Equivalent | |
| K092447 | DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES | FLL | Substantially Equivalent | |
| K092514 | UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES | DXN | Substantially Equivalent | |
| K041693 | WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES | DXN | Substantially Equivalent | |
| K041694 | DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETER | FLL | Substantially Equivalent | |
| K041692 | INFRARED EAR THERMOMETER, ET-100 SERIES | FLL | Substantially Equivalent | |
| K030361 | JASUN, MODELS DT-01F AND DT-11F | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003981912 | 3003981912 | HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., | Bldg,2,Baimiao Ind.Park,, Hangzhou Zhejiang 310023 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain