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FDA 510(k)

MUCHECK, VERSION 9.0

K-Number: K102583 · 2010-11-02

ApplicantOncology Data Systems, Inc.
Decision Date2010-11-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MUCHECK, VERSION 9.0 is the device name listed in this FDA 510(k) record. The listed applicant is Oncology Data Systems, Inc.. It received FDA 510(k) clearance on 2010-11-02 under 510(k) number K102583. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MUCHECK, VERSION 9.0?

MUCHECK, VERSION 9.0 is a medical device that received FDA 510(k) clearance on 2010-11-02. The listed applicant is Oncology Data Systems, Inc.. The 510(k) number is K102583.

When did MUCHECK, VERSION 9.0 receive FDA 510(k) clearance?

MUCHECK, VERSION 9.0 received FDA 510(k) clearance on 2010-11-02, under 510(k) number K102583.

Who is the listed applicant for MUCHECK, VERSION 9.0?

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

What is the FDA product code for MUCHECK, VERSION 9.0?

The FDA product code for MUCHECK, VERSION 9.0 is IYE.

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 Oncology Data Systems, 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.

K091602MUCHECK V8K061152MUCHECK V7.0K012227MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

Related Devices (Code: IYE)

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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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