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FDA 510(k)

BB-613 Watch Oximeter

K-Number: K181006 · 2018-09-21

ApplicantBio-Beat Technologies , Ltd.
Decision Date2018-09-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BB-613 Watch Oximeter is a medical device manufactured by Bio-Beat Technologies , Ltd.. It received FDA 510(k) clearance on 2018-09-21 under approval number K181006. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BB-613 Watch Oximeter?

BB-613 Watch Oximeter is a medical device that received FDA 510(k) clearance on 2018-09-21. It is manufactured by Bio-Beat Technologies , Ltd.. The 510(k) number is K181006.

When was BB-613 Watch Oximeter approved by the FDA?

BB-613 Watch Oximeter received FDA 510(k) clearance on 2018-09-21, under approval number K181006.

What company makes BB-613 Watch Oximeter?

BB-613 Watch Oximeter is manufactured by Bio-Beat Technologies , Ltd..

What is the FDA product code for BB-613 Watch Oximeter?

The FDA product code for BB-613 Watch Oximeter is DQA.

Related Devices (Code: DQA)

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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.

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