ANOLIFT - PORTABLE & ANOLIFT - GANTRY— 510(k) K902141

Substantially Equivalent

Anodyne Corp.

FDA 510(k) clearance K902141 for ANOLIFT - PORTABLE & ANOLIFT - GANTRY, Substantially Equivalent on 1990-09-12. Applicant: Anodyne Corp.. Device class: 1.

Clearance details

Applicant
Anodyne Corp.
Product code
Code FSA
Device class
Class 1
Regulation
21 CFR 880.5510
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brighton, MI, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code FSA

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Adverse events under product code FSA

product code FSA
Death
101
Injury
767
Malfunction
1,173
Other
1
Total
2,042

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.