SAFE'N'SOUND PASSIVE DELIVERY SYSTEM— 510(k) K101233

Name: FDA 510(k) clearance K101233
Creator: U.S. Food and Drug Administration
Published: 2011-02-18

Substantially Equivalent

Rexam Pharma

FDA 510(k) clearance K101233 for SAFE'N'SOUND PASSIVE DELIVERY SYSTEM, Substantially Equivalent on 2011-02-18. Applicant: Rexam Pharma. Device class: 2.

Clearance details

Applicant: Rexam Pharma
Product code: Code MEG
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2010-05-03
Decision date: 2011-02-18
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.