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FDA 510(k)

TRANSAMERICA DIGITAL EMS

K-Number: K010665 · 2001-04-27

ApplicantTransamerica Medical Systems
Decision Date2001-04-27
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

TRANSAMERICA DIGITAL EMS is the device name listed in this FDA 510(k) record. The listed applicant is Transamerica Medical Systems. It received FDA 510(k) clearance on 2001-04-27 under 510(k) number K010665. 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 TRANSAMERICA DIGITAL EMS?

TRANSAMERICA DIGITAL EMS is a medical device that received FDA 510(k) clearance on 2001-04-27. The listed applicant is Transamerica Medical Systems. The 510(k) number is K010665.

When did TRANSAMERICA DIGITAL EMS receive FDA 510(k) clearance?

TRANSAMERICA DIGITAL EMS received FDA 510(k) clearance on 2001-04-27, under 510(k) number K010665.

Who is the listed applicant for TRANSAMERICA DIGITAL EMS?

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

What is the FDA product code for TRANSAMERICA DIGITAL EMS?

The FDA product code for TRANSAMERICA DIGITAL EMS is IPF.

Related Clinical Trials

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Other records listing Transamerica Medical Systems 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.

K010782TRANSAMERICAN TENSK961749TRANSAMERICA ELECTRODE

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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