EZ-SPACER

Nebulizer (direct Patient Interface)

AIRPHARMA, LLC

The following data is part of a premarket notification filed by Airpharma, Llc with the FDA for Ez-spacer.

Pre-market Notification Details

• Device ID: K933090
• 510k Number: K933090
• Device Name: EZ-SPACER
• Classification: Nebulizer (direct Patient Interface)
• Applicant: AIRPHARMA, LLC P.O. BOX 1142 Ramona, CA 92065
• Contact: Tom Evangelisti
• Correspondent: Tom Evangelisti; AIRPHARMA, LLC P.O. BOX 1142 Ramona, CA 92065
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-06-24
• Decision Date: 1994-02-10