The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Humidifier Filter.
Device ID | K780535 |
510k Number | K780535 |
Device Name: | HUMIDIFIER FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-04-03 |
Decision Date | 1978-04-27 |