Aluna

Meter, Peak Flow, Spirometry

Knox Medical Diagnostics, Inc.

The following data is part of a premarket notification filed by Knox Medical Diagnostics, Inc. with the FDA for Aluna.

Pre-market Notification Details

• Device ID: K193311
• 510k Number: K193311
• Device Name: Aluna
• Classification: Meter, Peak Flow, Spirometry
• Applicant: Knox Medical Diagnostics, Inc. 345 California Street, Suite 600 San Francisco, CA 94104
• Contact: Charvi Shetty
• Correspondent: Pierre Bounaud; Acknowledge Regulatory Strategies 2251 San Diego Ave, Suite B-257 San Diego, CA 92110
• Product Code: BZH
• CFR Regulation Number: 868.1860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-11-29
• Decision Date: 2020-03-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00860000654005	K193311	000