The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Compact Portable Patient Monitor With Wireless Alan, Model Alilent M3000a/m3046a Option J120.
Device ID | K001664 |
510k Number | K001664 |
Device Name: | COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Contact | Dave Osborn |
Correspondent | Dave Osborn AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD. Andover, MA 01810 -1099 |
Product Code | MHX |
Subsequent Product Code | CCK |
Subsequent Product Code | DRT |
Subsequent Product Code | DRW |
Subsequent Product Code | DSI |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-31 |
Decision Date | 2000-06-30 |