CareView 1800Le
K-Number: K193173 · 2019-12-13
Decision Date2019-12-13
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CareView 1800Le is a medical device manufactured by Careray Digital Medical System Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under approval number K193173. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CareView 1800Le?
CareView 1800Le is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Careray Digital Medical System Co., Ltd.. The 510(k) number is K193173.
When was CareView 1800Le approved by the FDA?
CareView 1800Le received FDA 510(k) clearance on 2019-12-13, under approval number K193173.
What company makes CareView 1800Le?
CareView 1800Le is manufactured by Careray Digital Medical System Co., Ltd..
What is the FDA product code for CareView 1800Le?
The FDA product code for CareView 1800Le is MQB.
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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.