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FDA 510(k)

SyncVision System

K-Number: K161756 · 2016-09-05

ApplicantVolcano Corporation
Decision Date2016-09-05
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SyncVision System is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2016-09-05 under 510(k) number K161756. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SyncVision System?

SyncVision System is a medical device that received FDA 510(k) clearance on 2016-09-05. The listed applicant is Volcano Corporation. The 510(k) number is K161756.

When did SyncVision System receive FDA 510(k) clearance?

SyncVision System received FDA 510(k) clearance on 2016-09-05, under 510(k) number K161756.

Who is the listed applicant for SyncVision System?

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

What is the FDA product code for SyncVision System?

The FDA product code for SyncVision System is OWB.

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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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