510(k) K843046
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1984
- Date Received
- August 2, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Examining/Treatment, Ent
- Device Class
- Class I
- Regulation Number
- 874.5300
- Review Panel
- EN
- Submission Type