The following data is part of a premarket notification filed by Agilent Technologies with the FDA for Quikpage Arrhythmia Report Generator.
Device ID | K841083 |
510k Number | K841083 |
Device Name: | QUIKPAGE ARRHYTHMIA REPORT GENERATOR |
Classification | Detector And Alarm, Arrhythmia |
Applicant | AGILENT TECHNOLOGIES 20 N. AVADOR ST. Camarillo, CA 93010 |
Contact | William B Rich |
Correspondent | William B Rich AGILENT TECHNOLOGIES 20 N. AVADOR ST. Camarillo, CA 93010 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-13 |
Decision Date | 1985-02-07 |