MDT/HARVEY MC-8 AND MC-10— 510(k) K924955

Substantially Equivalent

Mdt Corp., Inc.

FDA 510(k) clearance K924955 for MDT/HARVEY MC-8 AND MC-10, Substantially Equivalent on 1993-10-15. Applicant: Mdt Corp., Inc..

Clearance details

Applicant: Mdt Corp., Inc.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1992-09-30
Decision date: 1993-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.