MODIFIED DR-2C/PMC 100— 510(k) K896153

Substantially Equivalent

General Devices

FDA 510(k) clearance K896153 for MODIFIED DR-2C/PMC 100, Substantially Equivalent on 1990-01-19. Applicant: General Devices.

Clearance details

Applicant: General Devices
Product code: Code DSH
Advisory panel: Cardiovascular
Date received: 1989-10-24
Decision date: 1990-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bogota, NJ, US

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Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.