510(k) K821079
K821079 is an FDA 510(k) premarket notification submitted by Ms. Kate Teaney for the device "ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG". The FDA issued a decision of Substantially Equivalent on May 10, 1982. The device falls under product code KLX (Electroglottograph), a Class II device regulated under 21 CFR 874.1325.
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