The following data is part of a premarket notification filed by Sunset Healthcare Solutions, Llc with the FDA for Sunset Healthcare Solutions Bacterial/viral Hme Filter, Model Bhf 104.
| Device ID | K102483 |
| 510k Number | K102483 |
| Device Name: | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | SUNSET HEALTHCARE SOLUTIONS, LLC 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SUNSET HEALTHCARE SOLUTIONS, LLC 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-30 |
| Decision Date | 2011-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10609038938216 | K102483 | 000 |