510(k) K914595
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 1992
- Date Received
- October 16, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter, Ear
- Device Class
- Class II
- Regulation Number
- 870.2710
- Review Panel
- AN
- Submission Type