AIRWAY PRESSURE MONITOR

Monitor, Airway Pressure (includes Gauge And/or Alarm)

RESPIRATORY SUPPORT PRODUCTS, INC.

The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Airway Pressure Monitor.

Pre-market Notification Details

Device IDK840420
510k NumberK840420
Device Name:AIRWAY PRESSURE MONITOR
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant RESPIRATORY SUPPORT PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-31
Decision Date1984-04-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.