The following data is part of a premarket notification filed by Agilent Technologies, Inc. with the FDA for Modification To Hp M2376a Device Link System, Model M2376a.
Device ID | K001776 |
510k Number | K001776 |
Device Name: | MODIFICATION TO HP M2376A DEVICE LINK SYSTEM, MODEL M2376A |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD., MS 0491 Andover, MA 01810 -1099 |
Contact | Mike Hudson |
Correspondent | Mike Hudson AGILENT TECHNOLOGIES, INC. 3000 MINUTEMAN RD., MS 0491 Andover, MA 01810 -1099 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-05-31 |
Decision Date | 2000-06-30 |