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FDA 510(k)

Q13 SPIROLYSER®

K-Number: K161676 · 2016-10-20

ApplicantFim Medical
Decision Date2016-10-20
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Q13 SPIROLYSER® is a medical device manufactured by Fim Medical. It received FDA 510(k) clearance on 2016-10-20 under approval number K161676. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q13 SPIROLYSER®?

Q13 SPIROLYSER® is a medical device that received FDA 510(k) clearance on 2016-10-20. It is manufactured by Fim Medical. The 510(k) number is K161676.

When was Q13 SPIROLYSER® approved by the FDA?

Q13 SPIROLYSER® received FDA 510(k) clearance on 2016-10-20, under approval number K161676.

What company makes Q13 SPIROLYSER®?

Q13 SPIROLYSER® is manufactured by Fim Medical.

What is the FDA product code for Q13 SPIROLYSER®?

The FDA product code for Q13 SPIROLYSER® is BZG.

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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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