Dozee VS
K-Number: K221555 · 2022-12-15
Decision Date2022-12-15
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Dozee VS is a medical device manufactured by Turtle Shell Technologies Private Limited. It received FDA 510(k) clearance on 2022-12-15 under approval number K221555. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dozee VS?
Dozee VS is a medical device that received FDA 510(k) clearance on 2022-12-15. It is manufactured by Turtle Shell Technologies Private Limited. The 510(k) number is K221555.
When was Dozee VS approved by the FDA?
Dozee VS received FDA 510(k) clearance on 2022-12-15, under approval number K221555.
What company makes Dozee VS?
Dozee VS is manufactured by Turtle Shell Technologies Private Limited.
What is the FDA product code for Dozee VS?
The FDA product code for Dozee VS is BZQ.
Related Devices (Code: BZQ)
K152911EarlySense Insight SytemEarlysense, Ltd.
K151940Thora-3Di, Model T-01Pneumacare Limited
K173976Masimo Acoustic Respiration Sensors, infant and neonateMasimo Corporation
K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor ActivationHill-Rom, Inc.
K171836EarlySense Bed Sensing UnitEarlysense, Ltd.
K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co. , Ltd.
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.