THE PEAK

Meter, Peak Flow, Spirometry

MULTISPIRO, INC.

The following data is part of a premarket notification filed by Multispiro, Inc. with the FDA for The Peak.

Pre-market Notification Details

• Device ID: K920390
• 510k Number: K920390
• Device Name: THE PEAK
• Classification: Meter, Peak Flow, Spirometry
• Applicant: MULTISPIRO, INC. 9A MASON Irvine, CA 92718
• Contact: Daniel Brown
• Correspondent: Daniel Brown; MULTISPIRO, INC. 9A MASON Irvine, CA 92718
• Product Code: BZH
• CFR Regulation Number: 868.1860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-01-30
• Decision Date: 1992-09-11