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FDA 510(k)

MYO-ACTUATOR

K-Number: K852963 · 1986-01-21

ApplicantVerimed Holdings, Inc.
Decision Date1986-01-21
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MYO-ACTUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Verimed Holdings, Inc.. It received FDA 510(k) clearance on 1986-01-21 under 510(k) number K852963. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYO-ACTUATOR?

MYO-ACTUATOR is a medical device that received FDA 510(k) clearance on 1986-01-21. The listed applicant is Verimed Holdings, Inc.. The 510(k) number is K852963.

When did MYO-ACTUATOR receive FDA 510(k) clearance?

MYO-ACTUATOR received FDA 510(k) clearance on 1986-01-21, under 510(k) number K852963.

Who is the listed applicant for MYO-ACTUATOR?

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

What is the FDA product code for MYO-ACTUATOR?

The FDA product code for MYO-ACTUATOR is HCC.

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Other records listing Verimed Holdings, 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.

K981277PERIFORMK954127BIOFEEDBACK DEVICEK951969MYOEXORCISER II FUALK930670PHYACTION 787K922550ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM)K913912VERIMED PERINEOMETER

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Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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