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FDA 510(k)

ACCUHEART ELECTRODE BELT

K-Number: K043361 · 2005-03-22

ApplicantAdvanced Bioelectric Corporation
Decision Date2005-03-22
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUHEART ELECTRODE BELT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Bioelectric Corporation. It received FDA 510(k) clearance on 2005-03-22 under 510(k) number K043361. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUHEART ELECTRODE BELT?

ACCUHEART ELECTRODE BELT is a medical device that received FDA 510(k) clearance on 2005-03-22. The listed applicant is Advanced Bioelectric Corporation. The 510(k) number is K043361.

When did ACCUHEART ELECTRODE BELT receive FDA 510(k) clearance?

ACCUHEART ELECTRODE BELT received FDA 510(k) clearance on 2005-03-22, under 510(k) number K043361.

Who is the listed applicant for ACCUHEART ELECTRODE BELT?

The FDA 510(k) record lists Advanced Bioelectric Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUHEART ELECTRODE BELT?

The FDA product code for ACCUHEART ELECTRODE BELT is DRX.

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Related Devices (Code: DRX)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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