AQUAVALVE

Drain, Tee (water Trap)

RESPIRATORY CARE, INC.

The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Aquavalve.

Pre-market Notification Details

• Device ID: K864147
• 510k Number: K864147
• Device Name: AQUAVALVE
• Classification: Drain, Tee (water Trap)
• Applicant: RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004
• Contact: Phyllis Piet-hughes
• Correspondent: Phyllis Piet-hughes; RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004
• Product Code: BYH
• CFR Regulation Number: 868.5995 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-22
• Decision Date: 1986-12-05