Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21

K-Number: K160347 · 2016-03-03

ApplicantQingdao Hisense Medical Equipment Co., Ltd.
Decision Date2016-03-03
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 is a medical device manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2016-03-03 under approval number K160347. The device is classified under product code PGY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21?

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K160347.

When was Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 approved by the FDA?

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 received FDA 510(k) clearance on 2016-03-03, under approval number K160347.

What company makes Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21?

Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 is manufactured by Qingdao Hisense Medical Equipment Co., Ltd..

What is the FDA product code for Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21?

The FDA product code for Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 is PGY.

Related Clinical Trials

NCT07496346 Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care Units NOT_YET_RECRUITING

Other Devices by Qingdao Hisense Medical Equipment Co., Ltd.

K222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D K222132Hisense LCD monitor HMD2G21S, HMD3G21S K221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) K213862HD60 Series Ultrasound Diagnostic System K233841HD80 Series Ultrasound Diagnostic System K233439HD60 Series Ultrasound Diagnostic System

View all 7 devices →

Related Devices (Code: PGY)

K1633356MP Color LCD Monitor, RadiForce RX660, RX660-AREizo Corporation K1625278MP Color LCD Monitor (C81W+)Shenzhen Beacon Display Technology Co., Ltd. K1624975MP Monochrome LCD Monitor, RadiForce GX550, GX550-AREizo Corporation K1618952MP Color LCD Monitor CCL214 (CL21214)Jvckenwood Corporation K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. K161229Mammo Tomosynthesis (MDMG-5221)Barco N.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑