510(k) K102483
K102483 is an FDA 510(k) premarket notification submitted by Sunset Healthcare Solutions, LLC for the device "SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104". The FDA issued a decision of Substantially Equivalent on Sep 13, 2011. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Sunset Healthcare Solutions, LLC has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 13, 2011
- Date Received
- Aug 30, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Filter, Bacterial, Breathing-Circuit
- Device Class
- Class II
- Regulation Number
- 868.5260
- Review Panel
- HO
- Submission Type
- 510(k)