The following data is part of a premarket notification filed by Vital Metrics, Inc. with the FDA for Urinary Monitoring Sys 240.
Device ID | K840917 |
510k Number | K840917 |
Device Name: | URINARY MONITORING SYS 240 |
Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
Applicant | VITAL METRICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNX |
CFR Regulation Number | 876.5250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-01 |
Decision Date | 1984-05-01 |