DeviceClearance

K981602

Substantially Equivalent

DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR

Applicant
Sunrise Medical Hhg, Inc.
Product code
BTA
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Somerset, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA
Death
5
Total
5

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.