The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Monaghan's Pressure Alarm.
| Device ID | K821649 |
| 510k Number | K821649 |
| Device Name: | MONAGHAN'S PRESSURE ALARM |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | MONAGHAN MEDICAL CORP. 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 | 1982-06-04 |
| Decision Date | 1982-08-05 |