The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Mri Ecg Patient Cable.
Device ID | K192852 |
510k Number | K192852 |
Device Name: | MRI ECG Patient Cable |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 |
Contact | Alejandra Aceves |
Correspondent | Alejandra Aceves Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-03 |
Decision Date | 2020-03-28 |