The following data is part of a premarket notification filed by Analogic Corp. with the FDA for C3 And Lifegard Icg Impedance Cardiography Monitors.
Device ID | K041434 |
510k Number | K041434 |
Device Name: | C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS |
Classification | Plethysmograph, Impedance |
Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Contact | Donald J Sherratt |
Correspondent | Donald J Sherratt ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-28 |
Decision Date | 2004-08-06 |
Summary: | summary |