The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Agilent M2636a Telemon Monitor.
Device ID | K001436 |
510k Number | K001436 |
Device Name: | AGILENT M2636A TELEMON MONITOR |
Classification | Detector And Alarm, Arrhythmia |
Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Denise Haley |
Correspondent | Denise Haley AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-08 |
Decision Date | 2000-06-07 |