FDA 510(k)

SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL

K-Number: K092479 · 2010-01-11

ApplicantDyn'R

Decision Date2010-01-11

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Dyn'R. It received FDA 510(k) clearance on 2010-01-11 under 510(k) number K092479. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL?

SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL is a medical device that received FDA 510(k) clearance on 2010-01-11. The listed applicant is Dyn'R. The 510(k) number is K092479.

When did SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL receive FDA 510(k) clearance?

SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL received FDA 510(k) clearance on 2010-01-11, under 510(k) number K092479.

Who is the listed applicant for SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL?

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

What is the FDA product code for SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL?

The FDA product code for SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL is IYE.

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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.