510(k) K982127
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1998
- Date Received
- June 17, 1998
- Clearance Type
- Special
- 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