PACHPEN PACHYMETER, MODEL 24-5100— 510(k) K050552

Substantially Equivalent

Accutome, Inc.

FDA 510(k) clearance K050552 for PACHPEN PACHYMETER, MODEL 24-5100, Substantially Equivalent on 2005-03-28. Applicant: Accutome, Inc..

Clearance details

Applicant: Accutome, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2005-03-03
Decision date: 2005-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

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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.