The following data is part of a premarket notification filed by Lifecare Services, Inc. with the FDA for Lota, Lifecare Oxygen/temperature Analyzer 36-001.
| Device ID | K880378 |
| 510k Number | K880378 |
| Device Name: | LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001 |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| 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 | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-27 |
| Decision Date | 1988-09-30 |