510(k) K841832
K841832 is an FDA 510(k) premarket notification submitted by Teltec Electronic Equipment AB for the device "GLOTTAL FREQUENCY ANALYSER". The FDA issued a decision of Substantially Equivalent on July 18, 1984. 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
- July 18, 1984
- Date Received
- May 3, 1984
- 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