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Hangzhou Hua'An Medical & Health Instruments Co.,

FDA Regulatory Profile

Hangzhou Hua'An Medical & Health Instruments Co., has 0 FDA recalls, 3 inspections, 10 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 17, 2015 · NAI
Latest 510(k)
Feb 13, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances10Oct 4, 2026Not statedCurrent
Inspections3Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 17, 2015Hangzhou, ChinaDevicesNo Action Indicated (NAI)3003981912
Jun 19, 2013Hangzhou, ChinaDevicesNo Action Indicated (NAI)3003981912
Sep 2, 2010Hangzhou, ChinaDevicesNo Action Indicated (NAI)3003981912

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K172870Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100JFeb 13, 2018
K172861Digital thermometer(with disposable thermometer cover)Dec 19, 2017
K160999Infra-red forehead thermometerAug 1, 2016
K122912DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER)Nov 7, 2012
K092447DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIESJan 7, 2010
K092514UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIESDec 4, 2009
K041693WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIESDec 2, 2004
K041694DIGITAL FLEXIBLE THERMOMETER, BASIC DIGITAL THERMOMETER, DITITAL PACIFIER THERMOMETERSep 13, 2004
K041692INFRARED EAR THERMOMETER, ET-100 SERIESSep 13, 2004
K030361JASUN, MODELS DT-01F AND DT-11FFeb 21, 2003

FDA data resources