Product Classification

• Device: analyzer, gas, oxygen, partial pressure, blood-phase, indwelling
• Regulation Description: Indwelling blood oxygen partial pressure (PO2) analyzer.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: CCE
• 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: 868.1200
• 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

Guidance Documents

• Guidance for Indwelling Blood Gas Analyzer 510(k) Submissions; Final

• Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc