SmartRead(TM) Medical Device Identifier (4100)— 510(k) DEN260007
UnknownBridgeSource Medical Corporation
FDA 510(k) clearance DEN260007 for SmartRead(TM) Medical Device Identifier (4100), Unknown on 2026-09-29. Applicant: BridgeSource Medical Corporation. Device class: 2.
Summary
SmartRead Medical Device Identifier (4100) is from BridgeSource Medical Corporation, filed under product code SJJ (Cardiac Device Identifier). The record doesn't describe the device beyond its name and code.
Class II, 21 CFR 870.3645. The record lists the submission type as Direct and the decision code as DENG. Cardiovascular is both the classification panel and the review panel.
BridgeSource filed from Austin, Texas. The decision came 189 calendar days after FDA received it (March 24 to September 29, 2026).
Clearance details
- Applicant
- BridgeSource Medical Corporation
- Product code
- Product code SJJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3645
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Austin, TX, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.