510(k) K972786
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1997
- Date Received
- July 25, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type