510(k) K950986
K950986 is an FDA 510(k) premarket notification submitted by Artronics for the device "NEUROREADER". The FDA issued a decision of Substantially Equivalent on November 9, 1995. The device falls under product code HCS (Device, Temperature Measurement, Direct Contact, Powered), a Class II device regulated under 21 CFR 882.1570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1995
- Date Received
- March 3, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Temperature Measurement, Direct Contact, Powered
- Device Class
- Class II
- Regulation Number
- 882.1570
- Review Panel
- NE
- Submission Type