BIOLOG— 510(k) K895534

Substantially Equivalent

Micromedical

FDA 510(k) clearance K895534 for BIOLOG, Substantially Equivalent on 1990-03-19. Applicant: Micromedical.

Clearance details

Applicant: Micromedical
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1989-09-13
Decision date: 1990-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gettysburg, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.