ISOLETTE INFANT INCUBATOR, MODEL C2HS— 510(k) K001242

Substantially Equivalent

Hill-Rom Air-Shields

FDA 510(k) clearance K001242 for ISOLETTE INFANT INCUBATOR, MODEL C2HS, Substantially Equivalent on 2000-07-13. Applicant: Hill-Rom Air-Shields.

Clearance details

Applicant: Hill-Rom Air-Shields
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2000-04-18
Decision date: 2000-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, 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.