The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Linde Oxygen Concentrator Model Loc-hc.
Device ID | K791043 |
510k Number | K791043 |
Device Name: | LINDE OXYGEN CONCENTRATOR MODEL LOC-HC |
Classification | Generator, Oxygen, Portable |
Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-05 |
Decision Date | 1979-06-13 |