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FDA 510(k)

CARDIODIRECT, MODELS 12M, 12I, 12S

K-Number: K024283 · 2003-08-01

ApplicantReynolds Medical , Ltd.
Decision Date2003-08-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIODIRECT, MODELS 12M, 12I, 12S is the device name listed in this FDA 510(k) record. The listed applicant is Reynolds Medical , Ltd.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K024283. 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 CARDIODIRECT, MODELS 12M, 12I, 12S?

CARDIODIRECT, MODELS 12M, 12I, 12S is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Reynolds Medical , Ltd.. The 510(k) number is K024283.

When did CARDIODIRECT, MODELS 12M, 12I, 12S receive FDA 510(k) clearance?

CARDIODIRECT, MODELS 12M, 12I, 12S received FDA 510(k) clearance on 2003-08-01, under 510(k) number K024283.

Who is the listed applicant for CARDIODIRECT, MODELS 12M, 12I, 12S?

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

What is the FDA product code for CARDIODIRECT, MODELS 12M, 12I, 12S?

The FDA product code for CARDIODIRECT, MODELS 12M, 12I, 12S is DPS.

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Other records listing Reynolds Medical , Ltd. as applicant

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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.

K254255S-Patch CardioAIWellysis Corp.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 Commercial

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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