510(k) K962292
K962292 is an FDA 510(k) premarket notification submitted by Emtech Laboratories for the device "HEARSAVER". The FDA issued a decision of Substantially Equivalent on October 29, 1996. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Emtech Laboratories has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 1996
- Date Received
- June 14, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Protector, Hearing (Insert)
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type