Cleared Traditional

Bodyport Cardiac Scale

K211585 · Bodyport, Inc. · Cardiovascular
Jul 2022
Decision
431d
Days
Class 2
Risk

About This 510(k) Submission

K211585 is an FDA 510(k) clearance for the Bodyport Cardiac Scale, a Plethysmograph, Impedance (Class II — Special Controls, product code DSB), submitted by Bodyport, Inc. (San Francisco, US). The FDA issued a Cleared decision on July 29, 2022, 431 days after receiving the submission on May 24, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2770.

Submission Details

510(k) Number K211585 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2021
Decision Date July 29, 2022
Days to Decision 431 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSB — Plethysmograph, Impedance
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2770