RHEO DOPPLEX II (RD 2)— 510(k) K964699

Substantially Equivalent

Huntleigh Technology, Inc.

FDA 510(k) clearance K964699 for RHEO DOPPLEX II (RD 2), Substantially Equivalent on 1997-02-21. Applicant: Huntleigh Technology, Inc..

Clearance details

Applicant: Huntleigh Technology, Inc.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1996-11-25
Decision date: 1997-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manalapan, NJ, US

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Adverse events under product code IYN

product code IYN

Death: 25
Injury: 163
Malfunction: 1,538
Other: 4
Total: 1,730

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.