NIOX VERO

System, Test, Breath Nitric Oxide

Circassia AB

The following data is part of a premarket notification filed by Circassia Ab with the FDA for Niox Vero.

Pre-market Notification Details

• Device ID: K170983
• 510k Number: K170983
• Device Name: NIOX VERO
• Classification: System, Test, Breath Nitric Oxide
• Applicant: Circassia AB Hanselligatan 13 Uppsala, SE Se-754 50
• Contact: Susanne Parks
• Correspondent: William Sammons; Circassia AB Hanselligatan 13 Uppsala, SE Se-754 50
• Product Code: MXA
• CFR Regulation Number: 862.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-03
• Decision Date: 2017-11-22
• Summary: summary