Neuro Scan Medical Systems A4000
FDA 510(k) K001562 · Neuro Scan Labs
510(k) numberK001562
Submission
- Device name
- Neuro Scan Medical Systems A4000
- Applicant
- Neuro Scan Labs
El Paso, TX, US - Received
- May 19, 2000
- Decision date
- August 16, 2000
- 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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Questions and answers
When was Neuro Scan Medical Systems A4000 cleared by the FDA?
Neuro Scan Medical Systems A4000 (K001562) received a 510(k) decision of Substantially Equivalent on August 16, 2000, 89 days after the submission was received.
What is the product code of K001562?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.