The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Catalog 6400 Oxygen Concentrator.
Device ID | K833938 |
510k Number | K833938 |
Device Name: | CATALOG 6400 OXYGEN CONCENTRATOR |
Classification | Generator, Oxygen, Portable |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 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 | 1983-11-15 |
Decision Date | 1983-12-08 |