510(k) K990240
K990240 is an FDA 510(k) premarket notification submitted by Kay Elemetrics Corp. for the device "ELECTROGLOTTOGRAPH". The FDA issued a decision of Substantially Equivalent on March 11, 1999. The device falls under product code KLX (Electroglottograph), a Class II device regulated under 21 CFR 874.1325. Kay Elemetrics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1999
- Date Received
- January 25, 1999
- 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