The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Penlon Breathing System Pressure Monitor.
| Device ID | K902381 |
| 510k Number | K902381 |
| Device Name: | PENLON BREATHING SYSTEM PRESSURE MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | PENLON, INC. 31, FRIENDS LN. P.O. BOX 739 Newtown, PA 18940 |
| Contact | Jim Gunnerson |
| Correspondent | Jim Gunnerson PENLON, INC. 31, FRIENDS LN. P.O. BOX 739 Newtown, PA 18940 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-08-17 |