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FDA 510(k)

MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1

K-Number: K012227 · 2001-10-01

ApplicantOncology Data Systems, Inc.
Decision Date2001-10-01
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 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 2001-10-01 under 510(k) number K012227. 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 - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1?

MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 is a medical device that received FDA 510(k) clearance on 2001-10-01. The listed applicant is Oncology Data Systems, Inc.. The 510(k) number is K012227.

When did MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 receive FDA 510(k) clearance?

MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 received FDA 510(k) clearance on 2001-10-01, under 510(k) number K012227.

Who is the listed applicant for MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1?

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 - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1?

The FDA product code for MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 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 9.0K091602MUCHECK V8K061152MUCHECK V7.0

Related Devices (Code: IYE)

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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