PATIENT WARMER- MODEL PW810— 510(k) K982636

Substantially Equivalent

Fisher & Paykel Healthcare, Ltd.

FDA 510(k) clearance K982636 for PATIENT WARMER- MODEL PW810, Substantially Equivalent on 1998-10-26. Applicant: Fisher & Paykel Healthcare, Ltd..

Clearance details

Applicant: Fisher & Paykel Healthcare, Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 1998-07-29
Decision date: 1998-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, New Zealand, NZ

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.