The following data is part of a premarket notification filed by Analogic Corp. with the FDA for C3 Patient Monitor.
Device ID | K030931 |
510k Number | K030931 |
Device Name: | C3 PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Contact | Marvin Rosenbaum |
Correspondent | Marvin Rosenbaum ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-25 |
Decision Date | 2003-05-09 |
Summary: | summary |