DeviceClearance

K232015

Substantially Equivalent

ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)

Applicant
Atmos Medizintechnik GmbH & Co. KG
Product code
EOB
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lenzkirch, DE
Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

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.