The following data is part of a premarket notification filed by Stanco Medical, Inc. with the FDA for Pressure Monitoring Lines.
Device ID | K802326 |
510k Number | K802326 |
Device Name: | PRESSURE MONITORING LINES |
Classification | Monitor, Line Isolation |
Applicant | STANCO MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRI |
CFR Regulation Number | 870.2620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-23 |
Decision Date | 1980-10-10 |