The following data is part of a premarket notification filed by Arbo Medical, Inc. with the FDA for Breathing Circuit Bacterial Filters.
| Device ID | K892520 |
| 510k Number | K892520 |
| Device Name: | BREATHING CIRCUIT BACTERIAL FILTERS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | ARBO MEDICAL, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
| Contact | Dawn I Moore |
| Correspondent | Dawn I Moore ARBO MEDICAL, INC. 3728 PLAZA DR. Ann Arbor, MI 48108 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-08-02 |