BOOMERANG ABSORPTION COMENSATION FILTER— 510(k) K853330

Substantially Equivalent

Entreprises Octostop, Inc.

FDA 510(k) clearance K853330 for BOOMERANG ABSORPTION COMENSATION FILTER, Substantially Equivalent on 1985-11-15. Applicant: Entreprises Octostop, Inc..

Clearance details

Applicant: Entreprises Octostop, Inc.
Product code: Code KPR
Advisory panel: Radiology
Date received: 1985-08-08
Decision date: 1985-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montreal, Canada H4l 421, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.