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FDA 510(k)

IFUSION

K-Number: K130656 · 2013-07-03

ApplicantOptovue, Inc.
Decision Date2013-07-03
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IFUSION is the device name listed in this FDA 510(k) record. The listed applicant is Optovue, Inc.. It received FDA 510(k) clearance on 2013-07-03 under 510(k) number K130656. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IFUSION?

IFUSION is a medical device that received FDA 510(k) clearance on 2013-07-03. The listed applicant is Optovue, Inc.. The 510(k) number is K130656.

When did IFUSION receive FDA 510(k) clearance?

IFUSION received FDA 510(k) clearance on 2013-07-03, under 510(k) number K130656.

Who is the listed applicant for IFUSION?

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

What is the FDA product code for IFUSION?

The FDA product code for IFUSION is HKI.

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Other records listing Optovue, Inc. as applicant

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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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