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FDA 510(k)

DIAGNOSOFT HARP

K-Number: K061368 · 2006-07-28

ApplicantDiagnosoft, Inc.
Decision Date2006-07-28
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSOFT HARP is the device name listed in this FDA 510(k) record. The listed applicant is Diagnosoft, Inc.. It received FDA 510(k) clearance on 2006-07-28 under 510(k) number K061368. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAGNOSOFT HARP?

DIAGNOSOFT HARP is a medical device that received FDA 510(k) clearance on 2006-07-28. The listed applicant is Diagnosoft, Inc.. The 510(k) number is K061368.

When did DIAGNOSOFT HARP receive FDA 510(k) clearance?

DIAGNOSOFT HARP received FDA 510(k) clearance on 2006-07-28, under 510(k) number K061368.

Who is the listed applicant for DIAGNOSOFT HARP?

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

What is the FDA product code for DIAGNOSOFT HARP?

The FDA product code for DIAGNOSOFT HARP is LNH.

Related Clinical Trials

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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Other records listing Diagnosoft, Inc. 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.

K111833VIRTUEK100352DIAGNOSOFT HARP MODEL 2.06

Related Devices (Code: LNH)

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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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