DeviceClearance

K010382

Substantially Equivalent

100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I

Applicant
Sensidyne, Inc.
Product code
CCL
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Clearwater, FL, US
Download summary PDF View 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.