MODEL 792 CONVERGE, MODEL 793 VISION 2000— 510(k) K945431

Name: FDA 510(k) clearance K945431
Creator: U.S. Food and Drug Administration
Published: 1995-01-25

Substantially Equivalent

Hausted, Inc.

FDA 510(k) clearance K945431 for MODEL 792 CONVERGE, MODEL 793 VISION 2000, Substantially Equivalent on 1995-01-25. Applicant: Hausted, Inc.. Device class: 2.

Clearance details

Applicant: Hausted, Inc.
Product code: Code FPO
Device class: Class 2
Regulation: 21 CFR 880.6910
Advisory panel: General Hospital
Date received: 1994-08-15
Decision date: 1995-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medina, OH, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FPO

product code FPO

Death: 29
Injury: 254
Malfunction: 5,054
Other: 10
Total: 5,347

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.