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FDA 510(k)

UM-D3000/UM-D4000

K-Number: K963985 · 1996-12-27

ApplicantJ.J. Consulting Services, Inc.
Decision Date1996-12-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UM-D3000/UM-D4000 is the device name listed in this FDA 510(k) record. The listed applicant is J.J. Consulting Services, Inc.. It received FDA 510(k) clearance on 1996-12-27 under 510(k) number K963985. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UM-D3000/UM-D4000?

UM-D3000/UM-D4000 is a medical device that received FDA 510(k) clearance on 1996-12-27. The listed applicant is J.J. Consulting Services, Inc.. The 510(k) number is K963985.

When did UM-D3000/UM-D4000 receive FDA 510(k) clearance?

UM-D3000/UM-D4000 received FDA 510(k) clearance on 1996-12-27, under 510(k) number K963985.

Who is the listed applicant for UM-D3000/UM-D4000?

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

What is the FDA product code for UM-D3000/UM-D4000?

The FDA product code for UM-D3000/UM-D4000 is GEI.

Related Devices (Code: GEI)

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.

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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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