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FDA 510(k)

ZX-I POWER ADD ON

K-Number: K123769 · 2013-05-10

ApplicantSpinergy, Inc.
Decision Date2013-05-10
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ZX-I POWER ADD ON is the device name listed in this FDA 510(k) record. The listed applicant is Spinergy, Inc.. It received FDA 510(k) clearance on 2013-05-10 under 510(k) number K123769. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZX-I POWER ADD ON?

ZX-I POWER ADD ON is a medical device that received FDA 510(k) clearance on 2013-05-10. The listed applicant is Spinergy, Inc.. The 510(k) number is K123769.

When did ZX-I POWER ADD ON receive FDA 510(k) clearance?

ZX-I POWER ADD ON received FDA 510(k) clearance on 2013-05-10, under 510(k) number K123769.

Who is the listed applicant for ZX-I POWER ADD ON?

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

What is the FDA product code for ZX-I POWER ADD ON?

The FDA product code for ZX-I POWER ADD ON is ITI.

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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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