510(k) K955018
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1996
- Date Received
- November 2, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ph, Stomach
- Device Class
- Class I
- Regulation Number
- 876.1400
- Review Panel
- GU
- Submission Type