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FDA 510(k)

DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111

K-Number: K970813 · 1997-05-08

ApplicantDenvu, Inc.
Decision Date1997-05-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 is the device name listed in this FDA 510(k) record. The listed applicant is Denvu, Inc.. It received FDA 510(k) clearance on 1997-05-08 under 510(k) number K970813. 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 DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111?

DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 is a medical device that received FDA 510(k) clearance on 1997-05-08. The listed applicant is Denvu, Inc.. The 510(k) number is K970813.

When did DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 receive FDA 510(k) clearance?

DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 received FDA 510(k) clearance on 1997-05-08, under 510(k) number K970813.

Who is the listed applicant for DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111?

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

What is the FDA product code for DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111?

The FDA product code for DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111 is LLZ.

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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.

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