510(k) K883853
K883853 is an FDA 510(k) premarket notification submitted by Sevrain-Tech, Inc. for the device "ETA". The FDA issued a decision of Substantially Equivalent on November 17, 1988. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device. Sevrain-Tech, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1988
- Date Received
- September 13, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Tactile
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type