510(k) K983817
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1999
- Date Received
- October 29, 1998
- 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