510(k) K781475
K781475 is an FDA 510(k) premarket notification submitted by Life-Tech Instruments, Inc. for the device "ELECTRODE IMPEDANCE TESTER-MODEL 500". The FDA issued a decision of Substantially Equivalent on September 7, 1978. The device falls under product code GYA (Tester, Electrode/Lead, Electroencephalograph), a Class I device regulated under 21 CFR 882.1410. Life-Tech Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1978
- Date Received
- August 28, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tester, Electrode/Lead, Electroencephalograph
- Device Class
- Class I
- Regulation Number
- 882.1410
- Review Panel
- NE
- Submission Type