Safe'n'Sound Staked Passive Delivery System - Plajex version— 510(k) K150562

Name: FDA 510(k) clearance K150562
Creator: U.S. Food and Drug Administration
Published: 2015-06-02

Substantially Equivalent

Nemera

FDA 510(k) clearance K150562 for Safe'n'Sound Staked Passive Delivery System - Plajex version, Substantially Equivalent on 2015-06-02. Applicant: Nemera. Device class: 2.

Clearance details

Applicant: Nemera
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2015-03-06
Decision date: 2015-06-02
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buffalo Grove, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.