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)

2MP Color LCD Monitor CL-R211

K-Number: K182539 · 2018-10-03

Decision Date2018-10-03
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

2MP Color LCD Monitor CL-R211 is the device name listed in this FDA 510(k) record. The listed applicant is Jvckenwood Corporation. It received FDA 510(k) clearance on 2018-10-03 under 510(k) number K182539. 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 2MP Color LCD Monitor CL-R211?

2MP Color LCD Monitor CL-R211 is a medical device that received FDA 510(k) clearance on 2018-10-03. The listed applicant is Jvckenwood Corporation. The 510(k) number is K182539.

When did 2MP Color LCD Monitor CL-R211 receive FDA 510(k) clearance?

2MP Color LCD Monitor CL-R211 received FDA 510(k) clearance on 2018-10-03, under 510(k) number K182539.

Who is the listed applicant for 2MP Color LCD Monitor CL-R211?

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 2MP Color LCD Monitor CL-R211?

The FDA product code for 2MP Color LCD Monitor CL-R211 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.

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.

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.