ISOVOL-EXCHANGE TRAY— 510(k) K852167

Name: FDA 510(k) clearance K852167
Creator: U.S. Food and Drug Administration
Published: 1985-11-18

Substantially Equivalent

Rocky Mountain Medical Corp.

FDA 510(k) clearance K852167 for ISOVOL-EXCHANGE TRAY, Substantially Equivalent on 1985-11-18. Applicant: Rocky Mountain Medical Corp.. Device class: 2.

Clearance details

Applicant: Rocky Mountain Medical Corp.
Product code: Code BRZ
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1985-05-20
Decision date: 1985-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BRZ

product code BRZ

Malfunction: 458
Total: 458

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.