510(k) K050953
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2005
- Date Received
- April 15, 2005
- 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