Insight Discovery
FDA 510(k) K063447 · Fasstech
510(k) numberK063447
Submission
- Device name
- Insight Discovery
- Applicant
- Fasstech
North Billerica, MA, US - Received
- November 15, 2006
- Decision date
- August 16, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Insight Discovery cleared by the FDA?
Insight Discovery (K063447) received a 510(k) decision of Substantially Equivalent on August 16, 2007, 274 days after the submission was received.
What is the product code of K063447?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.