FDA 510(k)

Biobeat Platform, BB-613WP Patch

K-Number: K212153 · 2022-03-25

Decision Date2022-03-25

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Biobeat Platform, BB-613WP Patch is a medical device manufactured by Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2022-03-25 under approval number K212153. 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 Biobeat Platform, BB-613WP Patch?

Biobeat Platform, BB-613WP Patch is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Biobeat Technologies , Ltd.. The 510(k) number is K212153.

When was Biobeat Platform, BB-613WP Patch approved by the FDA?

Biobeat Platform, BB-613WP Patch received FDA 510(k) clearance on 2022-03-25, under approval number K212153.

What company makes Biobeat Platform, BB-613WP Patch?

Biobeat Platform, BB-613WP Patch is manufactured by Biobeat Technologies , Ltd..

What is the FDA product code for Biobeat Platform, BB-613WP Patch?

The FDA product code for Biobeat Platform, BB-613WP Patch is DQA.

Other Devices by Biobeat Technologies , Ltd.

K190792BB-613WP K222010Biobeat Platform-2 and BB-613WP Patch K241066BB-613-BPM

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic 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.