Product Classification

• Device: meter, peak flow, spirometry
• Regulation Description: Peak-flow meter for spirometry.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: BZH
• Submission Type: 510(k)
• Regulation Number: 868.1860
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Guidance for Peak Flow Meters for Over-the-Counter Sale  

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.