Panda iRes Warmer, Giraffe Warmer— 510(k) K201628

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K201628 for Panda iRes Warmer, Giraffe Warmer, Substantially Equivalent on 2021-02-12. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code FMT
Advisory panel: General Hospital
Date received: 2020-06-16
Decision date: 2021-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wauwatosa, WI, US

Download summary PDF View on FDA.gov ↗

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.