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FDA 510(k)

E-PULSE

K-Number: K091875 · 2009-12-07

ApplicantMedevice Corporation
Decision Date2009-12-07
Product CodeBWK
DecisionSubstantially Equivalent

Device Summary

E-PULSE is the device name listed in this FDA 510(k) record. The listed applicant is Medevice Corporation. It received FDA 510(k) clearance on 2009-12-07 under 510(k) number K091875. The device is classified under product code BWK. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-PULSE?

E-PULSE is a medical device that received FDA 510(k) clearance on 2009-12-07. The listed applicant is Medevice Corporation. The 510(k) number is K091875.

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

E-PULSE received FDA 510(k) clearance on 2009-12-07, under 510(k) number K091875.

Who is the listed applicant for E-PULSE?

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

What is the FDA product code for E-PULSE?

The FDA product code for E-PULSE is BWK.

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Related Devices (Code: BWK)

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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