510(k) K000700— SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR

Substantially Equivalent

Sensidyne, Inc.

Clearance details

Applicant
Sensidyne, Inc.
Product code
Code CCL
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Clearwater, FL, US
Download summary PDFView on FDA.gov ↗

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.