The following data is part of a premarket notification filed by Hudson Respiratory Care, Inc. with the FDA for Bacteria/viral Filter.
| Device ID | K961914 |
| 510k Number | K961914 |
| Device Name: | BACTERIA/VIRAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Contact | Arden Morley |
| Correspondent | Arden Morley HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 Temecula, CA 92589 -9020 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704612653 | K961914 | 000 |
| 14026704658883 | K961914 | 000 |
| 24026704399387 | K961914 | 000 |
| 44026704399206 | K961914 | 000 |
| 44026704399114 | K961914 | 000 |
| 24026704717723 | K961914 | 000 |
| 34026704929055 | K961914 | 000 |
| 34026704929000 | K961914 | 000 |