Product Classification

• Device: nebulizer (direct patient interface)
• Regulation Description: Nebulizer.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: CAF
• Submission Type: 510(k)
• Regulation Number: 868.5630
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Guidance Document

• Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.