Pulse Oximeters

Form: Finger pulse oximeters, Handheld or portable devices, Wrist-worn oximeters

Strength: Range of accuracy (±2% or better)

Reference Brands: Masimo, Nonin, Omron, ChoiceMMed, AccuMed

Category: Medical Devices

Pulse oximeters sold in the US and EU are regulated to ensure safety, accuracy, and performance. In the US, FDA approval involves rigorous clinical validation and safety evaluations. In the EU, CE marking certifies conformity with in vitro diagnostic and medical device regulations. These devices undergo validation, stability testing, and thorough audits, with detailed documentation including safety profiles, performance data, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to reliable, accurate pulse oximeters vital for patient monitoring, especially during respiratory illnesses and COVID-19 worldwide.