OPTIVENT

Nebulizer (direct Patient Interface)

HEALTHCARE PRODUCTS, INC.

The following data is part of a premarket notification filed by Healthcare Products, Inc. with the FDA for Optivent.

Pre-market Notification Details

• Device ID: K963793
• 510k Number: K963793
• Device Name: OPTIVENT
• Classification: Nebulizer (direct Patient Interface)
• Applicant: HEALTHCARE PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292
• Contact: Lauren R Ziegler
• Correspondent: Lauren R Ziegler; HEALTHCARE PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 -1292
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-23
• Decision Date: 1997-04-16