EXSPIRON

Spirometer, Monitoring (w/wo Alarm)

RESPIRATORY MOTION, INC.

The following data is part of a premarket notification filed by Respiratory Motion, Inc. with the FDA for Exspiron.

Pre-market Notification Details

• Device ID: K120087
• 510k Number: K120087
• Device Name: EXSPIRON
• Classification: Spirometer, Monitoring (w/wo Alarm)
• Applicant: RESPIRATORY MOTION, INC. 411 WAVERLY OAKS ROAD BUILDING 1, SUITE 150 Waltham, MA 02452
• Contact: Chas Burr
• Correspondent: Chas Burr; RESPIRATORY MOTION, INC. 411 WAVERLY OAKS ROAD BUILDING 1, SUITE 150 Waltham, MA 02452
• Product Code: BZK
• CFR Regulation Number: 868.1850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-11
• Decision Date: 2012-09-26
• Summary: summary