FDA 510(k)

MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)

K-Number: K110410 · 2011-08-04

Decision Date2011-08-04

Product CodeGYC

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corp.. It received FDA 510(k) clearance on 2011-08-04 under 510(k) number K110410. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)?

MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) is a medical device that received FDA 510(k) clearance on 2011-08-04. The listed applicant is Nihon Kohden Corp.. The 510(k) number is K110410.

When did MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) receive FDA 510(k) clearance?

MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) received FDA 510(k) clearance on 2011-08-04, under 510(k) number K110410.

Who is the listed applicant for MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)?

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

What is the FDA product code for MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)?

The FDA product code for MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) is GYC.

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Official Source

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