WHISPERJECT AUTOINJECTOR— 510(k) K141384

Name: FDA 510(k) clearance K141384
Creator: U.S. Food and Drug Administration
Published: 2014-09-12

Substantially Equivalent

Scandinavian Health Limited

FDA 510(k) clearance K141384 for WHISPERJECT AUTOINJECTOR, Substantially Equivalent on 2014-09-12. Applicant: Scandinavian Health Limited. Device class: 2.

Clearance details

Applicant: Scandinavian Health Limited
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 2014-05-27
Decision date: 2014-09-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Deerfield Beach, FL, US

Download summary PDF View on FDA.gov ↗

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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.