Product Classification

• Device: oximeter
• Regulation Description: Oximeter.
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Anesthesiology
• Product Code: DQA
• Submission Type: 510(k)
• Regulation Number: 870.2700
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 80601-2-61 First edition 2011-04-01 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
• ISO 9919:2005: Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

Guidance Documents

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

Third Party Review

Not Third Party Eligible