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FDA 510(k)

MYOLAB II, MODEL ML-200

K-Number: K862236 · 1986-08-07

ApplicantMotion Control, Inc.
Decision Date1986-08-07
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYOLAB II, MODEL ML-200 is the device name listed in this FDA 510(k) record. The listed applicant is Motion Control, Inc.. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K862236. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOLAB II, MODEL ML-200?

MYOLAB II, MODEL ML-200 is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Motion Control, Inc.. The 510(k) number is K862236.

When did MYOLAB II, MODEL ML-200 receive FDA 510(k) clearance?

MYOLAB II, MODEL ML-200 received FDA 510(k) clearance on 1986-08-07, under 510(k) number K862236.

Who is the listed applicant for MYOLAB II, MODEL ML-200?

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

What is the FDA product code for MYOLAB II, MODEL ML-200?

The FDA product code for MYOLAB II, MODEL ML-200 is IKN.

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 Motion Control, 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.

K872040PHORESOR II (TM), MODEL PM700K802642UTAH ARTIFICAL ARMK780310DERMATRON IONTOPHORESIS DEVICE

Related Devices (Code: IKN)

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.

K172743Natus VikingQuestNatus Neurology IncorporatedK163150ViMove2Dorsavi, Ltd.K162383Cadwell Sierra Summit, Cadwell Sierra AscentCadwell Industries, Inc.K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)Oktx, LLCK123399MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.K113074CMAP PROMedical Technologies, Inc.

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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