ARTICULATE FITTING SYSTEM— 510(k) K973320

Substantially Equivalent

Decibel Instruments, Inc.

FDA 510(k) clearance K973320 for ARTICULATE FITTING SYSTEM, Substantially Equivalent on 1997-11-25. Applicant: Decibel Instruments, Inc..

Clearance details

Applicant: Decibel Instruments, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1997-09-03
Decision date: 1997-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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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.