The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Npb3900 Series Patient Monitors.
Device ID | K980411 |
510k Number | K980411 |
Device Name: | NPB3900 SERIES PATIENT MONITORS |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Contact | Steven A Clarke |
Correspondent | Steven A Clarke ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-03 |
Decision Date | 1998-08-20 |
Summary: | summary |