CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM— 510(k) K912240

Name: FDA 510(k) clearance K912240
Creator: U.S. Food and Drug Administration
Published: 1991-08-22

Substantially Equivalent

Mallinckrodt Anesthesia Products

FDA 510(k) clearance K912240 for CPAP SYSTEM AND BRONCHO-CATH W/CPAP SYSTEM, Substantially Equivalent on 1991-08-22. Applicant: Mallinckrodt Anesthesia Products. Device class: 2.

Clearance details

Applicant: Mallinckrodt Anesthesia Products
Product code: Code BYE
Device class: Class 2
Regulation: 21 CFR 868.5965
Advisory panel: Anesthesiology
Date received: 1991-05-21
Decision date: 1991-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYE

view all

K160112 — Besmed PEEP Valve2016-04-29
K133957 — DISPOSABLE ADJUSTABLE PEEP VALVE MR CONDITIONAL USE2014-04-14
K133210 — B&B BUBBLER2014-03-28
K122610 — PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES2013-08-05
K112546 — O_TWO CPAP SYSTEM2011-12-27

More clearances from Mallinckrodt Anesthesia Products

view all

K895875 — MODEL 4070 TEMPERATURE MONITOR1989-12-21
K890484 — HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE1989-04-21

Adverse events under product code BYE

product code BYE

Death: 5
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.