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FDA 510(k)

DOWNSCAN LT

K-Number: K974882 · 1998-05-22

ApplicantMerlin Engineering Works, Inc.
Decision Date1998-05-22
Product CodeLMD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOWNSCAN LT is the device name listed in this FDA 510(k) record. The listed applicant is Merlin Engineering Works, Inc.. It received FDA 510(k) clearance on 1998-05-22 under 510(k) number K974882. The device is classified under product code LMD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOWNSCAN LT?

DOWNSCAN LT is a medical device that received FDA 510(k) clearance on 1998-05-22. The listed applicant is Merlin Engineering Works, Inc.. The 510(k) number is K974882.

When did DOWNSCAN LT receive FDA 510(k) clearance?

DOWNSCAN LT received FDA 510(k) clearance on 1998-05-22, under 510(k) number K974882.

Who is the listed applicant for DOWNSCAN LT?

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

What is the FDA product code for DOWNSCAN LT?

The FDA product code for DOWNSCAN LT is LMD.

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Other records listing Merlin Engineering Works, 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.

K971154MULTIPICS(ME-977)K971153SPLITSCREEN (ME-975)K970451DOWNSCAN 120K970450UPSCAN 120K954211CRISPICSK953398UNISCAN

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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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