DAI-R— 510(k) K060141

Substantially Equivalent

Shl Medical, USA

FDA 510(k) clearance K060141 for DAI-R, Substantially Equivalent on 2006-06-12. Applicant: Shl Medical, USA.

Clearance details

Applicant: Shl Medical, USA
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2006-01-19
Decision date: 2006-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Florham Park, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.