Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
K-Number: K221113 · 2022-12-02
Decision Date2022-12-02
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-12-02 under approval number K221113. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor?
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K221113.
When was Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor approved by the FDA?
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor received FDA 510(k) clearance on 2022-12-02, under approval number K221113.
What company makes Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor?
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..
What is the FDA product code for Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor?
The FDA product code for Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor is MWI.
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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.