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FDA 510(k)

SYNC-RX SYSTEM, MODEL AS00010

K-Number: K100849 · 2010-05-21

ApplicantSync-Rx, Ltd.
Decision Date2010-05-21
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNC-RX SYSTEM, MODEL AS00010 is the device name listed in this FDA 510(k) record. The listed applicant is Sync-Rx, Ltd.. It received FDA 510(k) clearance on 2010-05-21 under 510(k) number K100849. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNC-RX SYSTEM, MODEL AS00010?

SYNC-RX SYSTEM, MODEL AS00010 is a medical device that received FDA 510(k) clearance on 2010-05-21. The listed applicant is Sync-Rx, Ltd.. The 510(k) number is K100849.

When did SYNC-RX SYSTEM, MODEL AS00010 receive FDA 510(k) clearance?

SYNC-RX SYSTEM, MODEL AS00010 received FDA 510(k) clearance on 2010-05-21, under 510(k) number K100849.

Who is the listed applicant for SYNC-RX SYSTEM, MODEL AS00010?

The FDA 510(k) record lists Sync-Rx, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNC-RX SYSTEM, MODEL AS00010?

The FDA product code for SYNC-RX SYSTEM, MODEL AS00010 is IZI.

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Related Devices (Code: IZI)

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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.

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