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FDA 510(k)

DIAGNOSOFT HARP MODEL 2.06

K-Number: K100352 · 2010-03-11

ApplicantDiagnosoft, Inc.
Decision Date2010-03-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIAGNOSOFT HARP MODEL 2.06 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnosoft, Inc.. It received FDA 510(k) clearance on 2010-03-11 under 510(k) number K100352. 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 MODEL 2.06?

DIAGNOSOFT HARP MODEL 2.06 is a medical device that received FDA 510(k) clearance on 2010-03-11. The listed applicant is Diagnosoft, Inc.. The 510(k) number is K100352.

When did DIAGNOSOFT HARP MODEL 2.06 receive FDA 510(k) clearance?

DIAGNOSOFT HARP MODEL 2.06 received FDA 510(k) clearance on 2010-03-11, under 510(k) number K100352.

Who is the listed applicant for DIAGNOSOFT HARP MODEL 2.06?

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 MODEL 2.06?

The FDA product code for DIAGNOSOFT HARP MODEL 2.06 is LNH.

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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.

K111833VIRTUEK061368DIAGNOSOFT HARP

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Official Source

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