The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Rci Viral/bacterial Filter.
| Device ID | K892230 |
| 510k Number | K892230 |
| Device Name: | RCI VIRAL/BACTERIAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Contact | Piet-hughes |
| Correspondent | Piet-hughes RESPIRATORY CARE, INC. 900 W. UNIVERSITY Arlington Heights, IL 60004 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-04 |
| Decision Date | 1989-08-28 |