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 the device name listed in this FDA 510(k) record. The listed applicant is Integrated Ophthalmic Systems, Inc.. It received FDA 510(k) clearance on 2020-03-16 under 510(k) 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. The listed applicant is Integrated Ophthalmic Systems, Inc.. The 510(k) number is K200385.

When did CONTINUUM PACS receive FDA 510(k) clearance?

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

Who is the listed applicant for CONTINUUM PACS?

The FDA 510(k) record lists Integrated Ophthalmic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTINUUM PACS?

The FDA product code for CONTINUUM PACS is NFJ.

Related Devices (Code: NFJ)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.