MINI PECG-MODIFICATION— 510(k) K841148

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K841148 for MINI PECG-MODIFICATION, Substantially Equivalent on 1984-04-17. Applicant: Intersect Systems, Inc..

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1984-03-21
Decision date: 1984-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.