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FDA 510(k)

CONTINUUM PACS

K-Number: K200385 · 2020-03-16

ApplicantIntegrated Ophthalmic Systems, Inc.
Decision Date2020-03-16
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CONTINUUM PACS is a medical device manufactured by Integrated Ophthalmic Systems, Inc.. It received FDA 510(k) clearance on 2020-03-16 under approval number K200385. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUUM PACS?

CONTINUUM PACS is a medical device that received FDA 510(k) clearance on 2020-03-16. It is manufactured by Integrated Ophthalmic Systems, Inc.. The 510(k) number is K200385.

When was CONTINUUM PACS approved by the FDA?

CONTINUUM PACS received FDA 510(k) clearance on 2020-03-16, under approval number K200385.

What company makes CONTINUUM PACS?

CONTINUUM PACS is manufactured by Integrated Ophthalmic Systems, Inc..

What is the FDA product code for CONTINUUM PACS?

The FDA product code for CONTINUUM PACS is NFJ.

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Official Source

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