DeviceClearance

Trilogy Evo— 510(k) K181166

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K181166 for Trilogy Evo, Substantially Equivalent on 2019-07-18. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant
Respironics, Inc.
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
Murrysville, PA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CBK

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More clearances from Respironics, Inc.

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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 K181166

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 K181166.

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