INFANT INCUBATOR, MODEL CHS-I1000— 510(k) K040910

Name: FDA 510(k) clearance K040910
Creator: U.S. Food and Drug Administration
Published: 2004-04-21

Substantially Equivalent

Choong Wae Medical Corp.

FDA 510(k) clearance K040910 for INFANT INCUBATOR, MODEL CHS-I1000, Substantially Equivalent on 2004-04-21. Applicant: Choong Wae Medical Corp.. Device class: 2.

Clearance details

Applicant: Choong Wae Medical Corp.
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 2004-04-08
Decision date: 2004-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.