Product Classification

• Device: oximeter
• Regulation Description: Oximeter.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Anesthesiology
• Product Code: DQA
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 870.2700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 1-139 ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02)
  Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
• 13-54 ISO IEEE 11073-10404 First edition 2010-05-01
  Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
• 13-134 IEEE ISO 11073-10404 Second edition 2022-12
  Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter

Guidance Document

• Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff

Third Party Review

Not Third Party Eligible