510(k) K851197
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 1985
- Date Received
- March 26, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Volume
- Device Class
- Class II
- Regulation Number
- 868.1760
- Review Panel
- AN
- Submission Type