The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Breathing Filter.
Device ID | K830618 |
510k Number | K830618 |
Device Name: | BREATHING FILTER |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | OHIO MEDICAL PRODUCTS 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 | 1983-02-28 |
Decision Date | 1983-04-08 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BREATHING FILTER 76357944 not registered Dead/Abandoned |
BRACKETT GREEN USA, INC. 2002-01-14 |