MEMOTHERM 10 BABY THERMOMETER— 510(k) K935280

Name: FDA 510(k) clearance K935280
Creator: U.S. Food and Drug Administration
Published: 1994-10-19

Substantially Equivalent

International Regulatory Consultants

FDA 510(k) clearance K935280 for MEMOTHERM 10 BABY THERMOMETER, Substantially Equivalent on 1994-10-19. Applicant: International Regulatory Consultants. Device class: 2.

Clearance details

Applicant: International Regulatory Consultants
Product code: Code FLL
Device class: Class 2
Regulation: 21 CFR 880.2910
Advisory panel: General Hospital
Date received: 1993-11-03
Decision date: 1994-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Efrat, Israel, IL

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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.