GUS831 Compressor Nebulizer
K-Number: K192633 · 2020-05-01
Decision Date2020-05-01
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
GUS831 Compressor Nebulizer is a medical device manufactured by Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under approval number K192633. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GUS831 Compressor Nebulizer?
GUS831 Compressor Nebulizer is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Globalcare Medical Technology Co., Ltd.. The 510(k) number is K192633.
When was GUS831 Compressor Nebulizer approved by the FDA?
GUS831 Compressor Nebulizer received FDA 510(k) clearance on 2020-05-01, under approval number K192633.
What company makes GUS831 Compressor Nebulizer?
GUS831 Compressor Nebulizer is manufactured by Globalcare Medical Technology Co., Ltd..
What is the FDA product code for GUS831 Compressor Nebulizer?
The FDA product code for GUS831 Compressor Nebulizer is CAF.
Other Devices by Globalcare Medical Technology Co., Ltd.
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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.