510(k) K063125
K063125 is an FDA 510(k) premarket notification submitted by Arc Medical, Inc. for the device "FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME)". The FDA issued a decision of Substantially Equivalent on April 13, 2007. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Arc Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2007
- Date Received
- October 13, 2006
- 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