PRIME CADI-120— 510(k) K914148

Name: FDA 510(k) clearance K914148
Creator: U.S. Food and Drug Administration
Published: 1992-10-05

Substantially Equivalent

Prime Medical Products, Inc.

FDA 510(k) clearance K914148 for PRIME CADI-120, Substantially Equivalent on 1992-10-05. Applicant: Prime Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Prime Medical Products, Inc.
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1991-09-16
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windermere, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.