The following data is part of a premarket notification filed by Eutectic Electronics, Inc. with the FDA for Accutracker Heart-rate Monitor.
| Device ID | K850867 |
| 510k Number | K850867 |
| Device Name: | ACCUTRACKER HEART-RATE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | EUTECTIC ELECTRONICS, INC. 8608 JERSEY COURT Raleigh, NC 27612 |
| Contact | David M Smith |
| Correspondent | David M Smith EUTECTIC ELECTRONICS, INC. 8608 JERSEY COURT Raleigh, NC 27612 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-01 |
| Decision Date | 1985-05-16 |