The following data is part of a premarket notification filed by Ferguson Medical with the FDA for An Pressure Monitor.
Device ID | K852826 |
510k Number | K852826 |
Device Name: | AN PRESSURE MONITOR |
Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | CAP |
CFR Regulation Number | 868.2600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-02 |
Decision Date | 1985-12-03 |