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FDA 510(k)

SolidAIRity III Airway Stabilization System

K-Number: K190630 · 2019-10-09

ApplicantSecurisyn Medical, LLC
Decision Date2019-10-09
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SolidAIRity III Airway Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Securisyn Medical, LLC. It received FDA 510(k) clearance on 2019-10-09 under 510(k) number K190630. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SolidAIRity III Airway Stabilization System?

SolidAIRity III Airway Stabilization System is a medical device that received FDA 510(k) clearance on 2019-10-09. The listed applicant is Securisyn Medical, LLC. The 510(k) number is K190630.

When did SolidAIRity III Airway Stabilization System receive FDA 510(k) clearance?

SolidAIRity III Airway Stabilization System received FDA 510(k) clearance on 2019-10-09, under 510(k) number K190630.

Who is the listed applicant for SolidAIRity III Airway Stabilization System?

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

What is the FDA product code for SolidAIRity III Airway Stabilization System?

The FDA product code for SolidAIRity III Airway Stabilization System is BTR.

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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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