510(k) K883869
K883869 is an FDA 510(k) premarket notification submitted by World Precision Instruments, Inc. for the device "DERMTRODE". The FDA issued a decision of Substantially Equivalent on September 30, 1988. The device falls under product code GYA (Tester, Electrode/Lead, Electroencephalograph), a Class I device regulated under 21 CFR 882.1410. World Precision Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1988
- Date Received
- September 13, 1988
- 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