ERA 3000 PACING SYSTEM ANALYZER— 510(k) K042708

Name: FDA 510(k) clearance K042708
Creator: U.S. Food and Drug Administration
Published: 2004-10-20

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K042708 for ERA 3000 PACING SYSTEM ANALYZER, Substantially Equivalent on 2004-10-20. Applicant: Biotronik, Inc.. Device class: 2.

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 2004-09-30
Decision date: 2004-10-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.