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FDA 510(k)

Biobeat Platform, BB-613WP Patch

K-Number: K212153 · 2022-03-25

ApplicantBiobeat Technologies , Ltd.
Decision Date2022-03-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Biobeat Platform, BB-613WP Patch is the device name listed in this FDA 510(k) record. The listed applicant is Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) 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. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K212153.

When did Biobeat Platform, BB-613WP Patch receive FDA 510(k) clearance?

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

Who is the listed applicant for Biobeat Platform, BB-613WP Patch?

The FDA 510(k) record lists Biobeat Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

NCT07240831Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)RECRUITING

Other records listing Biobeat Technologies , Ltd. as applicant

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.

K241066BB-613-BPMK222010Biobeat Platform-2 and BB-613WP PatchK190792BB-613WP

Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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