Phoenix Digital Thermometer— 510(k) K201032

Substantially Equivalent

Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.

FDA 510(k) clearance K201032 for Phoenix Digital Thermometer, Substantially Equivalent on 2021-10-29. Applicant: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd..

Clearance details

Applicant: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2020-04-20
Decision date: 2021-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mahape, Navi Mumbai, IN

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.