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)

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)

K-Number: K160326 · 2016-02-23

ApplicantJvckenwood Corporation
Decision Date2016-02-23
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is the device name listed in this FDA 510(k) record. The listed applicant is Jvckenwood Corporation. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K160326. 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 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)?

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Jvckenwood Corporation. The 510(k) number is K160326.

When did 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) receive FDA 510(k) clearance?

5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) received FDA 510(k) clearance on 2016-02-23, under 510(k) number K160326.

Who is the listed applicant for 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)?

The FDA 510(k) record lists Jvckenwood Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550)?

The FDA product code for 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) is PGY.

Other records listing Jvckenwood Corporation 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.

K2411053MP Color LCD Monitor (CL-S301)K2228648MP Color LCD Monitor CL-R813K2129856MP Color LCD Monitor CL-S600K20373312MP Color Digital Mammography LCD Monitor CL-S1200K2103452MP Monochrome LCD Monitor MS-S200K2001613MP Monochrome Digital Mammography LCD Monitor MS-S300

View all 11 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.

↑