MODEL 52 BUNN DRY AIR SUPPLY— 510(k) K800534

Name: FDA 510(k) clearance K800534
Creator: U.S. Food and Drug Administration
Published: 1980-03-25

Substantially Equivalent

Greene & Kellogg, Inc.

FDA 510(k) clearance K800534 for MODEL 52 BUNN DRY AIR SUPPLY, Substantially Equivalent on 1980-03-25. Applicant: Greene & Kellogg, Inc.. Device class: 2.

Clearance details

Applicant: Greene & Kellogg, Inc.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1980-03-07
Decision date: 1980-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K833495 — BUNN MICRO OXYGEN CONCENTRATOR1983-11-29
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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.