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FDA 510(k)

HOLOSCOPE-i

K-Number: K210072 · 2021-05-14

ApplicantReal View Imaging , Ltd.
Decision Date2021-05-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HOLOSCOPE-i is a medical device manufactured by Real View Imaging , Ltd.. It received FDA 510(k) clearance on 2021-05-14 under approval number K210072. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLOSCOPE-i?

HOLOSCOPE-i is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Real View Imaging , Ltd.. The 510(k) number is K210072.

When was HOLOSCOPE-i approved by the FDA?

HOLOSCOPE-i received FDA 510(k) clearance on 2021-05-14, under approval number K210072.

What company makes HOLOSCOPE-i?

HOLOSCOPE-i is manufactured by Real View Imaging , Ltd..

What is the FDA product code for HOLOSCOPE-i?

The FDA product code for HOLOSCOPE-i is LLZ.

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Official Source

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