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FDA 510(k)

ES 180-DCM MUSCLE STIMULATOR

K-Number: K860619 · 1986-05-30

ApplicantPromatek
Decision Date1986-05-30
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ES 180-DCM MUSCLE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Promatek. It received FDA 510(k) clearance on 1986-05-30 under 510(k) number K860619. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ES 180-DCM MUSCLE STIMULATOR?

ES 180-DCM MUSCLE STIMULATOR is a medical device that received FDA 510(k) clearance on 1986-05-30. The listed applicant is Promatek. The 510(k) number is K860619.

When did ES 180-DCM MUSCLE STIMULATOR receive FDA 510(k) clearance?

ES 180-DCM MUSCLE STIMULATOR received FDA 510(k) clearance on 1986-05-30, under 510(k) number K860619.

Who is the listed applicant for ES 180-DCM MUSCLE STIMULATOR?

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

What is the FDA product code for ES 180-DCM MUSCLE STIMULATOR?

The FDA product code for ES 180-DCM MUSCLE STIMULATOR is IPF.

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Related Devices (Code: IPF)

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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