The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lifecare Pressure Alarm Cat. No. 34-010.
| Device ID | K894361 |
| 510k Number | K894361 |
| Device Name: | LIFECARE PRESSURE ALARM CAT. NO. 34-010 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Contact | Harold Ellerington |
| Correspondent | Harold Ellerington LIFECARE SERVICES, INC. 655 ASPEN RIDGE DR. Lafayette, CO 80026 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-10-05 |