FDA 510(k)

DELTAMANAGER

K-Number: K933321 · 1993-11-03

Decision Date1993-11-03

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DELTAMANAGER is the device name listed in this FDA 510(k) record. The listed applicant is Medimage, Inc.. It received FDA 510(k) clearance on 1993-11-03 under 510(k) number K933321. 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 DELTAMANAGER?

DELTAMANAGER is a medical device that received FDA 510(k) clearance on 1993-11-03. The listed applicant is Medimage, Inc.. The 510(k) number is K933321.

When did DELTAMANAGER receive FDA 510(k) clearance?

DELTAMANAGER received FDA 510(k) clearance on 1993-11-03, under 510(k) number K933321.

Who is the listed applicant for DELTAMANAGER?

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

What is the FDA product code for DELTAMANAGER?

The FDA product code for DELTAMANAGER is KPS.

Related Clinical Trials

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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Other records listing Medimage, Inc. as applicant

K946334GALEN K922303M-LINK

Related Devices (Code: KPS)

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.