FDA.report

510(k) K212153

Device
Biobeat Platform, BB-613WP Patch
Applicant
BioBeat Technologies Ltd.
510(k) number
K212153
Product code
DQA  
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-25
Date received
2021-07-09
Regulation
870.2700
Classification name
Oximeter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Johanan May
Address
26 Ha'Magshimim St. Petah Tikvah IL 4934835 4934835

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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FDA Review

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