Product Classification

• Device: oximeter, reprocessed
• Regulation Description: Oximeter.
• Definition: same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Anesthesiology
• Product Code: NLF
• 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

• 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc