THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO— 510(k) K922383

Substantially Equivalent

Monitor Instruments, Inc.

FDA 510(k) clearance K922383 for THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO, Substantially Equivalent on 1993-01-15. Applicant: Monitor Instruments, Inc..

Clearance details

Applicant: Monitor Instruments, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1992-05-20
Decision date: 1993-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsborough, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.