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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 a medical device manufactured by Quantum-Spectra, LLC. It received FDA 510(k) clearance on 2020-06-02 under approval 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. It is manufactured by Quantum-Spectra, LLC. The 510(k) number is K200889.

When was iMac 27 & PL 4.0 approved by the FDA?

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

What company makes iMac 27 & PL 4.0?

iMac 27 & PL 4.0 is manufactured by Quantum-Spectra, LLC.

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

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

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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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