PUMA MODEL VERSION 1.0— 510(k) K100801

Substantially Equivalent

Prowess, Inc.

FDA 510(k) clearance K100801 for PUMA MODEL VERSION 1.0, Substantially Equivalent on 2010-06-18. Applicant: Prowess, Inc..

Clearance details

Applicant: Prowess, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2010-03-22
Decision date: 2010-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.