Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BB-613WP

K-Number: K190792 · 2019-08-22

ApplicantBiobeat Technologies , Ltd.
Decision Date2019-08-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BB-613WP 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 2019-08-22 under 510(k) 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. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K190792.

When did BB-613WP receive FDA 510(k) clearance?

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

Who is the listed applicant for BB-613WP?

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 BB-613WP?

The FDA product code for BB-613WP 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 PatchK212153Biobeat Platform, BB-613WP Patch

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑