DeviceClearance

WHISPER O2— 510(k) K931355

Substantially Equivalent

Trilogic Corp.

FDA 510(k) clearance K931355 for WHISPER O2, Substantially Equivalent on 1994-03-25. Applicant: Trilogic Corp.. Device class: 2.

Clearance details

Applicant
Trilogic Corp.
Product code
Code CAW
Device class
Class 2
Regulation
21 CFR 868.5440
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Littleton, CO, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CAW

view all

Adverse events under product code CAW

product code CAW
Death
204
Injury
573
Malfunction
1,400
Other
6
Total
2,183

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 →

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