The following data is part of a premarket notification filed by Penlon, Inc. with the FDA for Penlon Idp Pressure Failure Alarm.
| Device ID | K894689 |
| 510k Number | K894689 |
| Device Name: | PENLON IDP PRESSURE FAILURE ALARM |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | PENLON, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Contact | Stanley E Fry |
| Correspondent | Stanley E Fry PENLON, INC. 2085 RUSTIN AVE. Riverside, CA 92507 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-08-10 |