510(k) K850867
K850867 is an FDA 510(k) premarket notification submitted by Eutectic Electronics, Inc. for the device "ACCUTRACKER HEART-RATE MONITOR". The FDA issued a decision of Substantially Equivalent on May 16, 1985. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Eutectic Electronics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1985
- Date Received
- March 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type