Product Classification

• Device: spirometer, diagnostic
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BZG
• Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
• Submission Type: 510(k)
• Regulation Number: 868.1840
• 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

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

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