Cleared Traditional

K190792 - BB-613WP (FDA 510(k) Clearance)

K190792 · Biobeat Technologies , Ltd. · Cardiovascular device

Aug 2019

Decision

148d

Days

Class 2

Risk

K190792 is an FDA 510(k) clearance for the BB-613WP. This device is classified as a Oximeter (Class II - Special Controls, product code DQA).

Submitted by Biobeat Technologies , Ltd. (Petah Tikvah, IL). The FDA issued a Cleared decision on August 22, 2019, 148 days after receiving the submission on March 27, 2019.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K190792 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 2019
Decision Date	August 22, 2019
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF