510(k) K914538
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1992
- Date Received
- October 11, 1991
- 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