OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18— 510(k) K852374

Name: FDA 510(k) clearance K852374
Creator: U.S. Food and Drug Administration
Published: 1985-07-12

Substantially Equivalent

The Timeter Group

FDA 510(k) clearance K852374 for OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18, Substantially Equivalent on 1985-07-12. Applicant: The Timeter Group. Device class: 1.

Clearance details

Applicant: The Timeter Group
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1985-06-04
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.