MR EXTENSION SET (001)— 510(k) K964968

Substantially Equivalent

University of Michigan

FDA 510(k) clearance K964968 for MR EXTENSION SET (001), Substantially Equivalent on 1997-02-27. Applicant: University of Michigan.

Clearance details

Applicant: University of Michigan
Product code: Code FPA
Advisory panel: General Hospital
Date received: 1996-12-12
Decision date: 1997-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.