AERONEB PROFESSIONAL NEBULIZER SYSTEM

Nebulizer (direct Patient Interface)

AEROGEN (IRELAND) LTD

The following data is part of a premarket notification filed by Aerogen (ireland) Ltd with the FDA for Aeroneb Professional Nebulizer System.

Pre-market Notification Details

• Device ID: K070642
• 510k Number: K070642
• Device Name: AERONEB PROFESSIONAL NEBULIZER SYSTEM
• Classification: Nebulizer (direct Patient Interface)
• Applicant: AEROGEN (IRELAND) LTD GALWAY BUSINESS PARK Dangan, Galway, IE
• Contact: Frank Enright
• Correspondent: Frank Enright; AEROGEN (IRELAND) LTD GALWAY BUSINESS PARK Dangan, Galway, IE
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-08
• Decision Date: 2007-05-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391517937442	K070642	000
05391517935011	K070642	000
05391517935035	K070642	000
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