Insight Millennium III
FDA 510(k) K023209 · Fasstech
510(k) numberK023209
Submission
- Device name
- Insight Millennium III
- Applicant
- Fasstech
North Billerica, MA, US - Received
- September 26, 2002
- Decision date
- October 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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More from Spinematrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063447 | Insight DiscoveryIKN · Traditional | 08/16/2007SE |
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| K011964 | Insight Millennium PlusHCC · Traditional | 09/20/2001SE |
| K011983 | Insight GenesisHCC · Traditional | 08/30/2001SE |
| K990778 | Insight MillenniumHCC · Traditional | 06/03/1999SE |
| K961212 | Spinal TouchKQX · Traditional | 06/12/1996SE |
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Questions and answers
When was Insight Millennium III cleared by the FDA?
Insight Millennium III (K023209) received a 510(k) decision of Substantially Equivalent on October 10, 2003, 379 days after the submission was received.
What is the product code of K023209?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.