FDA 510(k)

MRI PPG Patient Cable

K-Number: K203653 · 2021-03-02

Decision Date2021-03-02

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MRI PPG Patient Cable is a medical device manufactured by Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 2021-03-02 under approval number K203653. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI PPG Patient Cable?

MRI PPG Patient Cable is a medical device that received FDA 510(k) clearance on 2021-03-02. It is manufactured by Ivy Biomedical Systems, Inc.. The 510(k) number is K203653.

When was MRI PPG Patient Cable approved by the FDA?

MRI PPG Patient Cable received FDA 510(k) clearance on 2021-03-02, under approval number K203653.

What company makes MRI PPG Patient Cable?

MRI PPG Patient Cable is manufactured by Ivy Biomedical Systems, Inc..

What is the FDA product code for MRI PPG Patient Cable?

The FDA product code for MRI PPG Patient Cable is LNH.

Other Devices by Ivy Biomedical Systems, Inc.

K151781Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor K170828Cardiac Trigger Monitor K171778MR Wireless Gating System, Model WGS-100 K192852MRI ECG Patient Cable K202138Cardiac Trigger Monitor K240087RT Carbon ECG Leads

View all 7 devices →

Related Devices (Code: LNH)

K162940MultiBand SENSEPhilips Medical Systems Nederland B.V. K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc. K162403HyperBandGe Medical Systems, LLC K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc. K161973G-scan Brio, S-scanEsaote, S.p.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.