K875270

Substantially Equivalent

INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS

Applicant: Air-Shields, Inc.
Product code: FMT
Advisory panel: General Hospital
Date received: 1987-12-22
Decision date: 1988-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.