SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)— 510(k) K971461

Substantially Equivalent

Fisher & Paykel Electronics , Ltd.

FDA 510(k) clearance K971461 for SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990), Substantially Equivalent on 1997-07-16. Applicant: Fisher & Paykel Electronics , Ltd..

Clearance details

Applicant: Fisher & Paykel Electronics , Ltd.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1997-04-21
Decision date: 1997-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, NZ

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.