COMPRESSOR, AIR, MINI-SILENT— 510(k) K781213

Name: FDA 510(k) clearance K781213
Creator: U.S. Food and Drug Administration
Published: 1978-07-27

Substantially Equivalent

The John Bunn Co.

FDA 510(k) clearance K781213 for COMPRESSOR, AIR, MINI-SILENT, Substantially Equivalent on 1978-07-27. Applicant: The John Bunn Co.. Device class: 2.

Clearance details

Applicant: The John Bunn Co.
Product code: Code BTI
Device class: Class 2
Regulation: 21 CFR 868.6250
Advisory panel: Anesthesiology
Date received: 1978-07-10
Decision date: 1978-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from The John Bunn Co.

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K900854 — JOHN BUNN: MEDIX COMPACT TRAVELLER1990-04-23
K883216 — BUNN MODEL 50 OXYGEN FLOW CONTROLLER1988-08-18
K873071 — BUNN CONCENTRATOR MODEL 2100 SERIES1987-09-15
K870094 — BUNN MODEL 530 ASPIRATOR1987-03-06
K861435 — BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE1986-11-07

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.