MODEL TM101 TEMPERATURE MONITOR— 510(k) K902386

Substantially Equivalent

Fisher & Paykel Electronics , Ltd.

FDA 510(k) clearance K902386 for MODEL TM101 TEMPERATURE MONITOR, Substantially Equivalent on 1992-01-28. Applicant: Fisher & Paykel Electronics , Ltd..

Clearance details

Applicant: Fisher & Paykel Electronics , Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1990-05-30
Decision date: 1992-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Auckland, New Zealand, NZ

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.