AL-200B Muscle Activity Integrator
FDA 510(k) K880976 · Aaron Laboratories, Inc.
510(k) numberK880976
Submission
- Device name
- AL-200B Muscle Activity Integrator
- Applicant
- Aaron Laboratories, Inc.
San Antonio, TX, US - Received
- March 8, 1988
- Decision date
- April 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 AL-200B Muscle Activity Integrator cleared by the FDA?
AL-200B Muscle Activity Integrator (K880976) received a 510(k) decision of Substantially Equivalent on April 13, 1988, 36 days after the submission was received.
What is the product code of K880976?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.