The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Air Compressor Adaptor Kit.
Device ID | K802253 |
510k Number | K802253 |
Device Name: | AIR COMPRESSOR ADAPTOR KIT |
Classification | Compressor, Air, Portable |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-16 |
Decision Date | 1980-09-26 |