TRAVELAIRE

Nebulizer, Medicinal, Non-ventilatory (atomizer)

B & F MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Travelaire.

Pre-market Notification Details

• Device ID: K811404
• 510k Number: K811404
• Device Name: TRAVELAIRE
• Classification: Nebulizer, Medicinal, Non-ventilatory (atomizer)
• Applicant: B & F MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: CCQ
• CFR Regulation Number: 868.5640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-18
• Decision Date: 1981-06-09