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)

iMac 27 & PL 4.0

K-Number: K200889 · 2020-06-02

ApplicantQuantum-Spectra, LLC
Decision Date2020-06-02
Product CodePGY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iMac 27 & PL 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Quantum-Spectra, LLC. It received FDA 510(k) clearance on 2020-06-02 under 510(k) number K200889. 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 iMac 27 & PL 4.0?

iMac 27 & PL 4.0 is a medical device that received FDA 510(k) clearance on 2020-06-02. The listed applicant is Quantum-Spectra, LLC. The 510(k) number is K200889.

When did iMac 27 & PL 4.0 receive FDA 510(k) clearance?

iMac 27 & PL 4.0 received FDA 510(k) clearance on 2020-06-02, under 510(k) number K200889.

Who is the listed applicant for iMac 27 & PL 4.0?

The FDA 510(k) record lists Quantum-Spectra, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iMac 27 & PL 4.0?

The FDA product code for iMac 27 & PL 4.0 is PGY.

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.

↑