The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Linde Oxygen Concentrator Model Loc-hca.
| Device ID | K781454 |
| 510k Number | K781454 |
| Device Name: | LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA |
| Classification | Titrimetric With Edta And Indicator, Calcium |
| Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHW |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-22 |
| Decision Date | 1978-09-20 |