C-200 INFANT INCUBATOR— 510(k) K822656

Name: FDA 510(k) clearance K822656
Creator: U.S. Food and Drug Administration
Published: 1982-10-18

Substantially Equivalent

Narco Scientific

FDA 510(k) clearance K822656 for C-200 INFANT INCUBATOR, Substantially Equivalent on 1982-10-18. Applicant: Narco Scientific. Device class: 2.

Clearance details

Applicant: Narco Scientific
Product code: Code FMZ
Device class: Class 2
Regulation: 21 CFR 880.5400
Advisory panel: General Hospital
Date received: 1982-09-03
Decision date: 1982-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.