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

FDA 510(k)

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor

K-Number: K183499 · 2019-02-04

ApplicantNanjing Jusha Display Technology Co., Ltd.
Decision Date2019-02-04
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Nanjing Jusha Display Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-02-04 under 510(k) number K183499. 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 JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor?

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is a medical device that received FDA 510(k) clearance on 2019-02-04. The listed applicant is Nanjing Jusha Display Technology Co., Ltd.. The 510(k) number is K183499.

When did JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor receive FDA 510(k) clearance?

JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor received FDA 510(k) clearance on 2019-02-04, under 510(k) number K183499.

Who is the listed applicant for JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor?

The FDA 510(k) record lists Nanjing Jusha Display Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor?

The FDA product code for JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is PGY.

Other records listing Nanjing Jusha Display Technology 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.

K230728JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD MonitorK231170C350/C350G LCD Monitor; M550/M550G LCD MonitorK230723C510G/JUSHA-C510G/C510/JUSHA- C510 LCD MonitorK230643CP620G LCD monitor, CP620 LCD monitorK222121C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitorK212231C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor

View all 15 devices →

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.

↑