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FDA 510(k)

DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300

K-Number: K081603 · 2009-07-24

ApplicantHeartforce Medical, Inc.
Decision Date2009-07-24
Product CodeDXR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 is the device name listed in this FDA 510(k) record. The listed applicant is Heartforce Medical, Inc.. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K081603. The device is classified under product code DXR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300?

DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Heartforce Medical, Inc.. The 510(k) number is K081603.

When did DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 receive FDA 510(k) clearance?

DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 received FDA 510(k) clearance on 2009-07-24, under 510(k) number K081603.

Who is the listed applicant for DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300?

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

What is the FDA product code for DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300?

The FDA product code for DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 is DXR.

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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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