The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Monarch (in 2125)/intellisystem (in 1125).
Device ID | K973230 |
510k Number | K973230 |
Device Name: | MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) |
Classification | Injector And Syringe, Angiographic |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Dennis Reigle |
Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-27 |
Decision Date | 1997-11-25 |
Summary: | summary |