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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 the device name listed in this FDA 510(k) record. The listed applicant is Caf Medical Solutions, Inc.. It received FDA 510(k) clearance on 2022-03-25 under 510(k) 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. The listed applicant is Caf Medical Solutions, Inc.. The 510(k) number is K220362.

When did LE-12CH receive FDA 510(k) clearance?

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

Who is the listed applicant for LE-12CH?

The FDA 510(k) record lists Caf Medical Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Caf Medical Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: DPS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, 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.

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