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FDA 510(k)

LE-12CH

K-Number: K220362 · 2022-03-25

ApplicantCaf Medical Solutions, Inc.
Decision Date2022-03-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LE-12CH is a medical device manufactured by Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-03-25 under approval number K220362. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LE-12CH?

LE-12CH is a medical device that received FDA 510(k) clearance on 2022-03-25. It is manufactured by Caf Medical Solutions, Inc.. The 510(k) number is K220362.

When was LE-12CH approved by the FDA?

LE-12CH received FDA 510(k) clearance on 2022-03-25, under approval number K220362.

What company makes LE-12CH?

LE-12CH is manufactured by Caf Medical Solutions, Inc..

What is the FDA product code for LE-12CH?

The FDA product code for LE-12CH is DPS.

Other Devices by Caf Medical Solutions, Inc.

K221879Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 K221616Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17

Related Devices (Code: DPS)

K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

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.

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