The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Penlon I.d.p. Presssure Failure Alarm.
| Device ID | K801254 |
| 510k Number | K801254 |
| Device Name: | PENLON I.D.P. PRESSSURE FAILURE ALARM |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | PENLON, 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 | 1980-05-28 |
| Decision Date | 1980-06-09 |