SmartTouch

Nebulizer (direct Patient Interface)

Adherium (NZ) Ltd

The following data is part of a premarket notification filed by Adherium (nz) Ltd with the FDA for Smarttouch.

Pre-market Notification Details

• Device ID: K163485
• 510k Number: K163485
• Device Name: SmartTouch
• Classification: Nebulizer (direct Patient Interface)
• Applicant: Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland, NZ 1010
• Contact: Chris Mander
• Correspondent: Chris Mander; Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland, NZ 1010
• Product Code: CAF
• CFR Regulation Number: 868.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-12
• Decision Date: 2017-08-30