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FDA 510(k)

E-POWER

K-Number: K010395 · 2001-05-11

ApplicantDalton Medical Corp.
Decision Date2001-05-11
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

E-POWER is the device name listed in this FDA 510(k) record. The listed applicant is Dalton Medical Corp.. It received FDA 510(k) clearance on 2001-05-11 under 510(k) number K010395. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-POWER?

E-POWER is a medical device that received FDA 510(k) clearance on 2001-05-11. The listed applicant is Dalton Medical Corp.. The 510(k) number is K010395.

When did E-POWER receive FDA 510(k) clearance?

E-POWER received FDA 510(k) clearance on 2001-05-11, under 510(k) number K010395.

Who is the listed applicant for E-POWER?

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

What is the FDA product code for E-POWER?

The FDA product code for E-POWER is ITI.

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Other records listing Dalton Medical Corp. as applicant

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Related Devices (Code: ITI)

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

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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