BREATHERITE

Nebulizer (direct Patient Interface)

VENTLAB CORP.

The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Breatherite.

Pre-market Notification Details

• Device ID: K981944
• 510k Number: K981944
• Device Name: BREATHERITE
• Classification: Nebulizer (direct Patient Interface)
• Applicant: VENTLAB CORP. PO BOX 4341 Crofton, MD 21114 -4341
• Contact: E.j. Smith
• Correspondent: E.j. Smith; VENTLAB CORP. PO BOX 4341 Crofton, MD 21114 -4341
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-06-03
• Decision Date: 1998-08-24