The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Mean Pressure Monitor.
Device ID | K810255 |
510k Number | K810255 |
Device Name: | MEAN PRESSURE MONITOR |
Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
Applicant | HEALTHDYNE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAP |
CFR Regulation Number | 868.2600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-30 |
Decision Date | 1981-02-12 |