MOBIL 02— 510(k) K864680

Name: FDA 510(k) clearance K864680
Creator: U.S. Food and Drug Administration
Published: 1987-01-09

Substantially Equivalent

Roman Laboratories, Inc.

FDA 510(k) clearance K864680 for MOBIL 02, Substantially Equivalent on 1987-01-09. Applicant: Roman Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Roman Laboratories, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1986-12-02
Decision date: 1987-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aurora, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.