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FDA 510(k)

CARDIAN III CR6A

K-Number: K864704 · 1987-03-20

ApplicantCardiac Recorders, Ltd.
Decision Date1987-03-20
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAN III CR6A is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Recorders, Ltd.. It received FDA 510(k) clearance on 1987-03-20 under 510(k) number K864704. 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 CARDIAN III CR6A?

CARDIAN III CR6A is a medical device that received FDA 510(k) clearance on 1987-03-20. The listed applicant is Cardiac Recorders, Ltd.. The 510(k) number is K864704.

When did CARDIAN III CR6A receive FDA 510(k) clearance?

CARDIAN III CR6A received FDA 510(k) clearance on 1987-03-20, under 510(k) number K864704.

Who is the listed applicant for CARDIAN III CR6A?

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

What is the FDA product code for CARDIAN III CR6A?

The FDA product code for CARDIAN III CR6A is DPS.

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Other records listing Cardiac Recorders, Ltd. 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.

K861621CARDIAN II CR45AK853673CARDIORATER CR 51K852910CARDIORATER CR7K852887CR5 CARDIAC MONITORK852905CR 280/45, CR281/4 DEFIBRILLATORK852808CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)

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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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