510(k) K901609
K901609 is an FDA 510(k) premarket notification submitted by Glottal Ent., Inc. for the device "ELECTROGLOTTOGRAPH". The FDA issued a decision of Substantially Equivalent on June 28, 1990. 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
- June 28, 1990
- Date Received
- April 6, 1990
- 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