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FDA 510(k)

EMS 3000

K-Number: K010745 · 2001-06-27

ApplicantDan Med, Inc.
Decision Date2001-06-27
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

EMS 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Dan Med, Inc.. It received FDA 510(k) clearance on 2001-06-27 under 510(k) number K010745. 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 EMS 3000?

EMS 3000 is a medical device that received FDA 510(k) clearance on 2001-06-27. The listed applicant is Dan Med, Inc.. The 510(k) number is K010745.

When did EMS 3000 receive FDA 510(k) clearance?

EMS 3000 received FDA 510(k) clearance on 2001-06-27, under 510(k) number K010745.

Who is the listed applicant for EMS 3000?

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

What is the FDA product code for EMS 3000?

The FDA product code for EMS 3000 is IPF.

Other records listing Dan Med, 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.

K013210TRUWAVEK012885NEUROMOVE NM900K991241IF8000K972997AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATIONK964738ELPHA 2000 CONTI

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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