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FDA 510(k)

SYNC-RX SYSTEM

K-Number: K132558 · 2013-12-12

ApplicantVolcano Corporation
Decision Date2013-12-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNC-RX 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 2013-12-12 under 510(k) number K132558. 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 SYNC-RX SYSTEM?

SYNC-RX SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-12. The listed applicant is Volcano Corporation. The 510(k) number is K132558.

When did SYNC-RX SYSTEM receive FDA 510(k) clearance?

SYNC-RX SYSTEM received FDA 510(k) clearance on 2013-12-12, under 510(k) number K132558.

Who is the listed applicant for SYNC-RX 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 SYNC-RX SYSTEM?

The FDA product code for SYNC-RX SYSTEM is OWB.

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Related Devices (Code: 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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