SANDMILL RMS— 510(k) K834512

Name: FDA 510(k) clearance K834512
Creator: U.S. Food and Drug Administration
Published: 1984-02-21

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K834512 for SANDMILL RMS, Substantially Equivalent on 1984-02-21. Applicant: Sandhill Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1983-12-21
Decision date: 1984-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.