K021344

Substantially Equivalent

B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM

Applicant
Vision-Sciences, Inc.
Product code
EOQ
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Ayer, MA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

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.