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FDA 510(k)

EKG VEST

K-Number: K932903 · 1995-02-24

ApplicantCardiotronics, Inc.
Decision Date1995-02-24
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKG VEST is the device name listed in this FDA 510(k) record. The listed applicant is Cardiotronics, Inc.. It received FDA 510(k) clearance on 1995-02-24 under 510(k) number K932903. 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 EKG VEST?

EKG VEST is a medical device that received FDA 510(k) clearance on 1995-02-24. The listed applicant is Cardiotronics, Inc.. The 510(k) number is K932903.

When did EKG VEST receive FDA 510(k) clearance?

EKG VEST received FDA 510(k) clearance on 1995-02-24, under 510(k) number K932903.

Who is the listed applicant for EKG VEST?

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

What is the FDA product code for EKG VEST?

The FDA product code for EKG VEST is DRX.

Other records listing Cardiotronics, Inc. as applicant

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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

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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