FDA 510(k)

BB-613WP

K-Number: K190792 · 2019-08-22

Decision Date2019-08-22

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BB-613WP is a medical device manufactured by Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2019-08-22 under approval number K190792. 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-613WP?

BB-613WP is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Biobeat Technologies , Ltd.. The 510(k) number is K190792.

When was BB-613WP approved by the FDA?

BB-613WP received FDA 510(k) clearance on 2019-08-22, under approval number K190792.

What company makes BB-613WP?

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

What is the FDA product code for BB-613WP?

The FDA product code for BB-613WP is DQA.

Other Devices by Biobeat Technologies , Ltd.

K222010Biobeat Platform-2 and BB-613WP Patch K212153Biobeat Platform, 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.