510(k) K010040
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2001
- Date Received
- January 5, 2001
- 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