The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Breathing Circuit Bacteria Filter.
| Device ID | K831856 |
| 510k Number | K831856 |
| Device Name: | BREATHING CIRCUIT BACTERIA FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Terence D Wall |
| Correspondent | Terence D Wall VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-09 |
| Decision Date | 1983-09-26 |