FDA 510(k)

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES

K-Number: K072789 · 2007-10-19

Decision Date2007-10-19

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES is the device name listed in this FDA 510(k) record. The listed applicant is Encision, Inc.. It received FDA 510(k) clearance on 2007-10-19 under 510(k) number K072789. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES?

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES is a medical device that received FDA 510(k) clearance on 2007-10-19. The listed applicant is Encision, Inc.. The 510(k) number is K072789.

When did DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES receive FDA 510(k) clearance?

DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES received FDA 510(k) clearance on 2007-10-19, under 510(k) number K072789.

Who is the listed applicant for DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES?

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

What is the FDA product code for DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES?

The FDA product code for DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES is GEI.

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Other records listing Encision, Inc. as applicant

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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.