DeviceClearance

Puritan Bennett 980 Series Ventilator System— 510(k) K193056

Substantially Equivalent

Covidien, LLC

FDA 510(k) clearance K193056 for Puritan Bennett 980 Series Ventilator System, Substantially Equivalent on 2020-11-20. Applicant: Covidien, LLC. Device class: 2.

Clearance details

Applicant
Covidien, LLC
Product code
Code CBK
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CBK

product code CBK
Death
736
Injury
3,628
Malfunction
98,786
Other
4
Total
103,154

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K193056

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193056.

Data sourced from openFDA. This site is unofficial and independent of the FDA.