DeviceClearance

OXICHECK— 510(k) K023565

Substantially Equivalent

Caradyne, Ltd.

FDA 510(k) clearance K023565 for OXICHECK, Substantially Equivalent on 2003-03-28. Applicant: Caradyne, Ltd.. Device class: 2.

Clearance details

Applicant
Caradyne, Ltd.
Product code
Code CCL
Device class
Class 2
Regulation
21 CFR 868.1720
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Mccordsville, IN, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code CCL

view all

More clearances from Caradyne, Ltd.

view all

Adverse events under product code CCL

product code CCL
Other
2
Total
2

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.