Cersr Electromyography System
FDA 510(k) K110048 · Spinematrix, Inc.
510(k) numberK110048
Submission
- Device name
- Cersr Electromyography System
- Applicant
- Spinematrix, Inc.
Philedelphia, PA, US - Received
- January 6, 2011
- Decision date
- January 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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Questions and answers
When was Cersr Electromyography System cleared by the FDA?
Cersr Electromyography System (K110048) received a 510(k) decision of Substantially Equivalent on January 26, 2011, 20 days after the submission was received.
What is the product code of K110048?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.