MACROVAC— 510(k) K801127

Substantially Equivalent

Progress Mankind Technology

FDA 510(k) clearance K801127 for MACROVAC, Substantially Equivalent on 1980-05-30. Applicant: Progress Mankind Technology.

Clearance details

Applicant: Progress Mankind Technology
Product code: Code JOL
Advisory panel: General Hospital
Date received: 1980-05-12
Decision date: 1980-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hopkins, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOL

product code JOL

Death: 7
Injury: 177
Malfunction: 1,306
Other: 1
Total: 1,491

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.