DIAMOND MEDICAL, INC., MODEL DM 700— 510(k) K863298

Name: FDA 510(k) clearance K863298
Creator: U.S. Food and Drug Administration
Published: 1987-03-17

Substantially Equivalent

Diamond Medical, Inc.

FDA 510(k) clearance K863298 for DIAMOND MEDICAL, INC., MODEL DM 700, Substantially Equivalent on 1987-03-17. Applicant: Diamond Medical, Inc.. Device class: 1.

Clearance details

Applicant: Diamond Medical, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1986-08-25
Decision date: 1987-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, 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.