510(k) K973162
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 1997
- Date Received
- August 22, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Patient Position, Light-Beam
- Device Class
- Class I
- Regulation Number
- 892.5780
- Review Panel
- RA
- Submission Type