MS-120BK Electric Stimulator (Extension Unit)
FDA 510(k) K110410 · Nihon Kohden Corp.
510(k) numberK110410
Submission
- Device name
- MS-120BK Electric Stimulator (Extension Unit)
- Applicant
- Nihon Kohden Corp.
Foothill, CA, US - Received
- February 14, 2011
- Decision date
- August 4, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MS-120BK Electric Stimulator (Extension Unit) cleared by the FDA?
MS-120BK Electric Stimulator (Extension Unit) (K110410) received a 510(k) decision of Substantially Equivalent on August 4, 2011, 171 days after the submission was received.
What is the product code of K110410?
The FDA product code is GYC – Electrode, Cortical, a Class II (moderate risk) device regulated under 21 CFR 882.1310.