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 |