510(k) K945978
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1995
- Date Received
- December 8, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type