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FDA 510(k)

PROFILE ONE OMNI

K-Number: K882559 · 1988-08-08

ApplicantModular Diagnostic Systems, Inc.
Decision Date1988-08-08
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROFILE ONE OMNI is the device name listed in this FDA 510(k) record. The listed applicant is Modular Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882559. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE ONE OMNI?

PROFILE ONE OMNI is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is Modular Diagnostic Systems, Inc.. The 510(k) number is K882559.

When did PROFILE ONE OMNI receive FDA 510(k) clearance?

PROFILE ONE OMNI received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882559.

Who is the listed applicant for PROFILE ONE OMNI?

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

What is the FDA product code for PROFILE ONE OMNI?

The FDA product code for PROFILE ONE OMNI is JJE.

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Related Devices (Code: JJE)

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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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