K914864

Substantially Equivalent

MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR

Applicant: Air-Shields, Inc.
Product code: FMZ
Advisory panel: General Hospital
Date received: 1991-10-29
Decision date: 1992-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

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.