ISOLETTE INCUBATOR C-100— 510(k) K802126

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K802126 for ISOLETTE INCUBATOR C-100, Substantially Equivalent on 1980-09-26. Applicant: Narco Air-Shields.

Clearance details

Applicant: Narco Air-Shields
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1980-09-04
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.