510(k) K843433
K843433 is an FDA 510(k) premarket notification submitted by Spectro Industries, Inc. for the device "KANIEVSKI SENSORY AID OR DEVICE". The FDA issued a decision of Substantially Equivalent on November 14, 1984. The device falls under product code LRA (Hearing Aid, Tactile), a Class U device. Spectro Industries, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1984
- Date Received
- September 4, 1984
- 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