510(k) K821079
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 1982
- Date Received
- April 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electroglottograph
- Device Class
- Class II
- Regulation Number
- 874.1325
- Review Panel
- EN
- Submission Type