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FDA 510(k)

Dozee VS

K-Number: K221555 · 2022-12-15

ApplicantTurtle Shell Technologies Private Limited
Decision Date2022-12-15
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Dozee VS is the device name listed in this FDA 510(k) record. The listed applicant is Turtle Shell Technologies Private Limited. It received FDA 510(k) clearance on 2022-12-15 under 510(k) 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. The listed applicant is Turtle Shell Technologies Private Limited. The 510(k) number is K221555.

When did Dozee VS receive FDA 510(k) clearance?

Dozee VS received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221555.

Who is the listed applicant for Dozee VS?

The FDA 510(k) record lists Turtle Shell Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dozee VS?

The FDA product code for Dozee VS is BZQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07223931Validating Dozee for Contactless Monitoring of Heart, Breathing, and MovemenCOMPLETEDNCT07735403Dozee Validation for Contactless Heart Rate and Respiration Monitoring in Clinical SettingsRECRUITING

Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

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.

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