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FDA 510(k)

MUCHECK V8

K-Number: K091602 · 2009-06-18

ApplicantOncology Data Systems, Inc.
Decision Date2009-06-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MUCHECK V8 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 2009-06-18 under 510(k) number K091602. 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 V8?

MUCHECK V8 is a medical device that received FDA 510(k) clearance on 2009-06-18. The listed applicant is Oncology Data Systems, Inc.. The 510(k) number is K091602.

When did MUCHECK V8 receive FDA 510(k) clearance?

MUCHECK V8 received FDA 510(k) clearance on 2009-06-18, under 510(k) number K091602.

Who is the listed applicant for MUCHECK V8?

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 V8?

The FDA product code for MUCHECK V8 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.

K102583MUCHECK, VERSION 9.0K061152MUCHECK V7.0K012227MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

Related Devices (Code: IYE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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