SUPERLOGGER— 510(k) K912772

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K912772 for SUPERLOGGER, Substantially Equivalent on 1992-02-07. Applicant: Sandhill Scientific, Inc..

Clearance details

Applicant
Sandhill Scientific, Inc.
Product code
Code FFT
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Littleton, CO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code FFT

product code FFT
Injury
595
Malfunction
2,175
Other
1
Total
2,771

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.