MOD 427— 510(k) K834277

Substantially Equivalent

Hoffrel Instruments, Inc.

FDA 510(k) clearance K834277 for MOD 427, Substantially Equivalent on 1984-02-17. Applicant: Hoffrel Instruments, Inc..

Clearance details

Applicant: Hoffrel Instruments, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1983-10-31
Decision date: 1984-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.