510(k) clearance

SmartRead(TM) Medical Device Identifier (4100)

FDA 510(k) source

510(k) number

DEN260007

Applicant

BridgeSource Medical Corporation

Decision date

Sep 29, 2026

Date received

Mar 24, 2026

Decision

Unknown

Clearance type

Direct

Product code

SJJ

Device type

Cardiac Device Identifier

Device class

Class II

Regulation

21 CFR 870.3645

Advisory committee

Cardiovascular

Third party

N

Location

Austin, TX, US