510(k) K840487
K840487 is an FDA 510(k) premarket notification submitted by K.J. Electronics for the device "T-METER". The FDA issued a decision of Substantially Equivalent on March 12, 1984. 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
- March 12, 1984
- Date Received
- February 6, 1984
- 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