MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT— 510(k) K875369

Substantially Equivalent

Diamond Medical, Inc.

FDA 510(k) clearance K875369 for MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT, Substantially Equivalent on 1988-02-05. Applicant: Diamond Medical, Inc..

Clearance details

Applicant: Diamond Medical, Inc.
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1987-12-31
Decision date: 1988-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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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.