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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 the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2016-03-03 under 510(k) 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. The listed applicant is Qingdao Hisense Medical Equipment Co., Ltd.. The 510(k) number is K160347.

When did Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 receive FDA 510(k) clearance?

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

Who is the listed applicant for Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21?

The FDA 510(k) record lists Qingdao Hisense Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Qingdao Hisense Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233841HD80 Series Ultrasound Diagnostic SystemK233439HD60 Series Ultrasound Diagnostic SystemK222208Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30DK222132Hisense LCD monitor HMD2G21S, HMD3G21SK221567LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)K213862HD60 Series Ultrasound Diagnostic System

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Related Devices (Code: PGY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261213Medical Monitor (40HT513D)Lg Electronics.IncK252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.K252030RadiForce GX570; RadiForce GX570-AREizo CorporationK243221RadiForce RX570; RadiForce RX570-AREizo CorporationK243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.

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.

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