ANESTHASSIST— 510(k) K871564

Substantially Equivalent

Anestech, Inc.

FDA 510(k) clearance K871564 for ANESTHASSIST, Substantially Equivalent on 1987-05-18. Applicant: Anestech, Inc..

Clearance details

Applicant
Anestech, Inc.
Product code
Code BRY
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Payson, AZ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BRY

product code BRY
Death
9
Malfunction
75,890
Total
75,899

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.