510(k) K853832
K853832 is an FDA 510(k) premarket notification submitted by Amdev, Inc. for the device "LYTENING 1". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Amdev, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1985
- Date Received
- September 13, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Ion Specific, Sodium
- Device Class
- Class II
- Regulation Number
- 862.1665
- Review Panel
- CH
- Submission Type