FDA 510(k)

AUTOMATED MEDICAL REPORT WRITER

K-Number: K981553 · 1998-09-29

Decision Date1998-09-29

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AUTOMATED MEDICAL REPORT WRITER is the device name listed in this FDA 510(k) record. The listed applicant is Woodson and Associates, LLC. It received FDA 510(k) clearance on 1998-09-29 under 510(k) number K981553. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED MEDICAL REPORT WRITER?

AUTOMATED MEDICAL REPORT WRITER is a medical device that received FDA 510(k) clearance on 1998-09-29. The listed applicant is Woodson and Associates, LLC. The 510(k) number is K981553.

When did AUTOMATED MEDICAL REPORT WRITER receive FDA 510(k) clearance?

AUTOMATED MEDICAL REPORT WRITER received FDA 510(k) clearance on 1998-09-29, under 510(k) number K981553.

Who is the listed applicant for AUTOMATED MEDICAL REPORT WRITER?

The FDA 510(k) record lists Woodson and Associates, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATED MEDICAL REPORT WRITER?

The FDA product code for AUTOMATED MEDICAL REPORT WRITER is KPS.

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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.