510(k) K770268
K770268 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "SYS. FOR REC. BSER RESPONSES". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1977
- Date Received
- February 11, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type