E-PASS— 510(k) K113148

Name: FDA 510(k) clearance K113148
Creator: U.S. Food and Drug Administration
Published: 2012-02-28

Substantially Equivalent

Synexmed(Shenzhen)Company Limited

FDA 510(k) clearance K113148 for E-PASS, Substantially Equivalent on 2012-02-28. Applicant: Synexmed(Shenzhen)Company Limited. Device class: 2.

Clearance details

Applicant: Synexmed(Shenzhen)Company Limited
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 2011-10-24
Decision date: 2012-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.