MOBIL C-ARM, REGURBISHED, VARIOUS MODELS— 510(k) K950971

Substantially Equivalent

Pro-Tronics, Inc.

FDA 510(k) clearance K950971 for MOBIL C-ARM, REGURBISHED, VARIOUS MODELS, Substantially Equivalent on 1995-04-11. Applicant: Pro-Tronics, Inc..

Clearance details

Applicant: Pro-Tronics, Inc.
Product code: Code JAA
Advisory panel: Radiology
Date received: 1995-02-21
Decision date: 1995-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gilberts, IL, US

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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.