MODIFICATION OF ANTERIOR SEGMENT ELECTRODES— 510(k) K933527

Substantially Equivalent

Mira, Inc.

FDA 510(k) clearance K933527 for MODIFICATION OF ANTERIOR SEGMENT ELECTRODES, Substantially Equivalent on 1994-01-25. Applicant: Mira, Inc..

Clearance details

Applicant: Mira, Inc.
Product code: Code HWA
Advisory panel: Orthopedic
Date received: 1993-07-20
Decision date: 1994-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

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Adverse events under product code HWA

product code HWA

Malfunction: 12,146
Other: 2
Total: 12,148

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.