INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD— 510(k) K974588

Substantially Equivalent

Rimed , Ltd.

FDA 510(k) clearance K974588 for INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD, Substantially Equivalent on 1998-08-07. Applicant: Rimed , Ltd..

Clearance details

Applicant: Rimed , Ltd.
Product code: Code IYN
Advisory panel: Radiology
Date received: 1997-12-09
Decision date: 1998-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot Shomron 44853, IL

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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.