IMPALA— 510(k) K913512

Substantially Equivalent

Pin Dot Products, Inc.

FDA 510(k) clearance K913512 for IMPALA, Substantially Equivalent on 1991-08-29. Applicant: Pin Dot Products, Inc..

Clearance details

Applicant: Pin Dot Products, Inc.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 1991-08-07
Decision date: 1991-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Niles, IL, US

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Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.