FDA 510(k)

Celerity ECG Cable Accessory Pack

K-Number: K171931 · 2017-10-26

ApplicantMedcomp (Medical Components, Inc.)

Decision Date2017-10-26

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Celerity ECG Cable Accessory Pack is a medical device manufactured by Medcomp (Medical Components, Inc.). It received FDA 510(k) clearance on 2017-10-26 under approval number K171931. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celerity ECG Cable Accessory Pack?

Celerity ECG Cable Accessory Pack is a medical device that received FDA 510(k) clearance on 2017-10-26. It is manufactured by Medcomp (Medical Components, Inc.). The 510(k) number is K171931.

When was Celerity ECG Cable Accessory Pack approved by the FDA?

Celerity ECG Cable Accessory Pack received FDA 510(k) clearance on 2017-10-26, under approval number K171931.

What company makes Celerity ECG Cable Accessory Pack?

Celerity ECG Cable Accessory Pack is manufactured by Medcomp (Medical Components, Inc.).

What is the FDA product code for Celerity ECG Cable Accessory Pack?

The FDA product code for Celerity ECG Cable Accessory Pack is LJS.

Other Devices by Medcomp (Medical Components, Inc.)

K153246PTFE Super Sheath Introducer 2.1 K162271Pro-Lock CT Safety Infusion Set

Related Devices (Code: LJS)

K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) K162443PowerPICC Provena CathetersC.R. Bard, Inc. K161496Turbo-Flo PICC SetsCook Incorporated K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex K153469Cathtong I PICC CatheterL&Z Us, Inc. K151985PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH CatheterC.R. Bard, Inc.

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.