The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Recomed Cardiac Output Meter 236067-.
Device ID | K840439 |
510k Number | K840439 |
Device Name: | RECOMED CARDIAC OUTPUT METER 236067- |
Classification | Computer, Diagnostic, Pre-programmed, Single-function |
Applicant | LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
Contact | Robert L Casarsa |
Correspondent | Robert L Casarsa LITTON MEDICAL ELECTRONICS 777 NICHOLAS BLVD. Elk Grove Village, IL 60007 |
Product Code | DXG |
CFR Regulation Number | 870.1435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-01 |
Decision Date | 1984-11-20 |