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FDA 510(k)

DOWNSCAN 120

K-Number: K970451 · 1997-04-07

ApplicantMerlin Engineering Works, Inc.
Decision Date1997-04-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOWNSCAN 120 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 1997-04-07 under 510(k) number K970451. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOWNSCAN 120?

DOWNSCAN 120 is a medical device that received FDA 510(k) clearance on 1997-04-07. The listed applicant is Merlin Engineering Works, Inc.. The 510(k) number is K970451.

When did DOWNSCAN 120 receive FDA 510(k) clearance?

DOWNSCAN 120 received FDA 510(k) clearance on 1997-04-07, under 510(k) number K970451.

Who is the listed applicant for DOWNSCAN 120?

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 120?

The FDA product code for DOWNSCAN 120 is LLZ.

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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.

K974882DOWNSCAN LTK971154MULTIPICS(ME-977)K971153SPLITSCREEN (ME-975)K970450UPSCAN 120K954211CRISPICSK953398UNISCAN

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Related Devices (Code: LLZ)

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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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