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 |