The following data is part of a premarket notification filed by Argon Medical Corp. with the FDA for Monitoring Kit, Central Venous Pressure.
Device ID | K770290 |
510k Number | K770290 |
Device Name: | MONITORING KIT, CENTRAL VENOUS PRESSURE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | ARGON MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-14 |
Decision Date | 1977-03-15 |