VOYAGER PX— 510(k) K895082

Name: FDA 510(k) clearance K895082
Creator: U.S. Food and Drug Administration
Published: 1990-01-09

Substantially Equivalent

Smith-Perry Corp.

FDA 510(k) clearance K895082 for VOYAGER PX, Substantially Equivalent on 1990-01-09. Applicant: Smith-Perry Corp.. Device class: 2.

Clearance details

Applicant: Smith-Perry Corp.
Product code: Code BYJ
Device class: Class 2
Regulation: 21 CFR 868.5655
Advisory panel: Anesthesiology
Date received: 1989-08-14
Decision date: 1990-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riviera Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BYJ

product code BYJ

Death: 16
Total: 16

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.