REGER Nebulizer Irrigation Cannula
K-Number: K231622 · 2023-09-29
ApplicantReger Medizintechnik, GmbH
Decision Date2023-09-29
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
REGER Nebulizer Irrigation Cannula is a medical device manufactured by Reger Medizintechnik, GmbH. It received FDA 510(k) clearance on 2023-09-29 under approval number K231622. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the REGER Nebulizer Irrigation Cannula?
REGER Nebulizer Irrigation Cannula is a medical device that received FDA 510(k) clearance on 2023-09-29. It is manufactured by Reger Medizintechnik, GmbH. The 510(k) number is K231622.
When was REGER Nebulizer Irrigation Cannula approved by the FDA?
REGER Nebulizer Irrigation Cannula received FDA 510(k) clearance on 2023-09-29, under approval number K231622.
What company makes REGER Nebulizer Irrigation Cannula?
REGER Nebulizer Irrigation Cannula is manufactured by Reger Medizintechnik, GmbH.
What is the FDA product code for REGER Nebulizer Irrigation Cannula?
The FDA product code for REGER Nebulizer Irrigation Cannula is GCJ.
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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.